Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

SR. SUPPLIER DEVELOPMENT ENGINEER (STARLINK)

SpaceX is leveraging our experience building rockets and spacecraft to deploy Starlink, the world’s largest satellite constellation and most advanced broadband internet system. We provide reliable and fast internet to millions of users worldwide, including populations with little or no connectivity, rural communities, aircraft, watercraft, and places where existing services are unreliable, too expensive, or disconnected by natural disasters. We design, build, test, and operate all parts of the system, thousands of satellites and consumer antennae that allow users to connect within minutes of unboxing. The Starlink team is seeking out the best-in-class professionals to maximize Starlink’s potential for communities and businesses around the globe.

This is a high-profile, cross-functional position that plays an integral role in enabling development and production flow of Starlink user terminals. You will work in close coordination with internal engineering and manufacturing departments as well as directly with suppliers to execute effective, creative, and smart supply chain strategies to achieve production goals. With integration taking place in-house, supplier development engineers are able to see their assemblies come to life every day!

RESPONSIBILITIES:

• Improve quality, cost, delivery, and capacity metrics for mechanical hardware used in Starlink user terminals
• Collaborate with design, materials, and manufacturing engineers to gain an in-depth knowledge of piece part, assembly, metrology, and/or sub-system design intent
• Support the procurement team to strategically source parts matched with supplier competencies by reviewing and assessing supplier manufacturing processes and quality systems
• Create and define supplier technical and quality requirements based on customer and program requirements and expectations for NPI and production phases
• Lead resolution of supplier quality issues through root cause analysis, while functioning as liaison between purchasing, engineering, production, and suppliers
• Define product technical requirements, and ensure supplier compliance with these requirements
• Implement and monitor the production part approval process (PPAP) with selected suppliers to enable rate production
• Analyze supplier quality and delivery metrics to identify trends and pinpoint systemic performance gaps and root causes to drive supplier improvement plans
• Conduct independent research to identify potential new suppliers and capabilities in manufacturing and metrology
• Identify and drive product & process improvements to lower part cost, reduce supply risk, eliminate potential defects, and improve cycle time
• Effectively manage mission-critical supply chain by establishing excellent working relationships and regular lines of communication with suppliers
• Demonstrate a strong sense of ownership, proactivity, technical excellence, creativity, self-direction, and courage
• Collaborate with teams, lead projects, and continuously drive improvement in the supply base

BASIC QUALIFICATIONS:

• Bachelor’s degree in an engineering discipline
• 6+ years of experience in one of the following: supply chain engineering, supplier development/quality, manufacturing, design engineering

PREFERRED SKILLS AND EXPERIENCE:

• Master’s degree in and engineering discipline, business, or supply chain
• 10+ years of experience in one of the following: supply chain engineering, supplier development/quality, manufacturing, design engineering
• Proven track record of taking ownership of projects, negotiating successfully to reduce costs, and influencing engineering customers to drive results
• Knowledge of statistical techniques and methods (design of experiments, Six Sigma, etc.)
• Proficiency in Geometric Dimensioning and Tolerancing (GDT) principles and applications
• Knowledge of metrology tools and techniques for measuring and characterizing mechanical parts
• Knowledge of lean, production, and supply chain concepts
• Exceptional analytical, problem-solving, time management, and organizational skills
• Ability to act quickly in a fast-moving and high-stress environment

ADDITIONAL REQUIREMENTS:

• Must be willing to work extended hours and weekends as needed to meet critical deadlines
• Ability to travel: Up to 50% work week travel may be required
• Valid driver’s license

What’s in it for you?

Opportunity To Unlock Your Creativity
Think of all the times you were held back from trying new ideas because you were boxed in by bureaucratic legacy processes or old school tactics. Having a growth mindset is deeply ingrained into our company culture since day 1 so Fictiv is an environment where you have the creative liberty and support of the team to try big bold ideas to achieve our sales and customer goals.

Opportunity To Grow Your Career
There are plenty of sales jobs out there. The question is whether any of them will help you grow in your career? Will you be challenged by teammates to achieve your potential? Or are they roles that will ask you to do more of what you've already mastered. At Fictiv, you'll be surrounded by supportive teammates who will push you to be your best through their curiosity and passion.

Impact In This Role

We bridge the gap between complex customer requirements and practical manufacturing solutions by accurately interpreting technical drawings, performing precise cost analysis, and ensuring manufacturability through DFM (Design for Manufacturability) reviews. We engage directly with customers to clarify requirements, address technical questions, and provide transparent guidance that balances cost, quality, and lead time.

We streamline quoting workflows by reducing manual touchpoints, standardizing processes, and enabling faster decision-making. We proactively identify risks whether in material sourcing, tolerance challenges, or production feasibility and work with cross-functional teams to resolve them before they impact delivery.

Our work enhances the customer experience by combining deep technical expertise with clear, timely communication. We act as the link between customer needs and manufacturing capabilities, ensuring quotes are accurate, timelines are realistic, and outcomes meet or exceed expectations.

You will report to the Global Solution Engineering Director.

What You’ll Be Doing

• Accurate & Timely Quoting

  • Provide cost estimates for CNC machining and other manufacturing processes with high precision.

  • Perform DFM (Design for Manufacturability) analysis to highlight risks, suggest design changes, and optimize for cost and lead time.

  • Apply process knowledge to quote complex parts confidently, even in challenging timelines.

• Technical Support & Expertise

  • Interpret engineering drawings, GD&T, and material requirements to ensure feasibility.

  • Provide alternatives for difficult-to-source materials or complex geometries.

  • Offer process guidance for machining, finishing, and assembly needs.

  • Deliver region-specific manufacturing expertise across the US, India, China, and Mexico. Optimized to match the customer’s unique requirements, budget constraints, lead time goals, and project priorities.

• Customer Engagement & Education

  • Direct communication with customers to clarify requirements, resolve design concerns, and ensure alignment on expectations.

  • Provide proactive updates during quoting or project execution to reduce uncertainty.

  • Educate customers on trade-offs between cost, lead time, and quality.

• Cross-functional Collaboration

  • Work with internal teams (Sales, Operations, Sourcing, Quality & Logistics) to ensure smooth project execution.

  • Engage with manufacturing partners to validate capabilities, pricing, and delivery timelines.

• Risk Identification & Mitigation

  • Detect potential manufacturing challenges early, reducing costly rework or delays.

  • Recommend alternative manufacturing processes, tolerances, or materials when required.

• Platform-driven Quoting Solutions

  • Leverage platform tools to automate portions of the quoting process for speed and accuracy.

  • Balance risk by determining when to quote on-platform vs. escalate to High Touch (HT) quoting.

Desired Traits

• Meticulous, detail oriented, inclination for documentation
• Excellent verbal and written communication skills in English required
• Self-starter, manages time efficiently, able to complete work in a timely manner without active supervision
• Enjoys sharing knowledge and teaching others about manufacturing processes
• 4-year Mechanical Engineering degree or equivalent technical training
• Understanding of GD&T and conventional (coordinate) tolerancing
• Knowledge of manufacturability, and limitations, of common metals and plastics
• Exposure to multiple custom mechanical manufacturing processes (sheet metal, urethane casting, injection molding, etc…)
• CNC machining and 3D printing experience is a must

What’s in it for you?

Opportunity To Unlock Your Creativity
Think of all the times you were held back from trying new ideas because you were boxed in by bureaucratic legacy processes or old school tactics. Having a growth mindset is deeply ingrained into our company culture since day 1 so Fictiv is an environment where you have the creative liberty and support of the team to try big bold ideas to achieve our sales and customer goals.

Opportunity To Grow Your Career
Fictiv, you'll be surrounded by supportive teammates who will push you to be your best through their curiosity and passion.

Impact In This Role

Your role as a Manufacturing Engineer will be to support and drive improvement to our critical manufacturing functions. We have two sets of customers—our builders, who order parts through us, and our manufacturing partners, who manufacture and assemble these parts—and you’ll be consistently working at the interface between the two.  At Fictiv, we believe in creating the world’s premier platform for hardware manufacturing, and you’ll be playing a critical role in making that happen.

In your role as the Manufacturing Engineer, you will be reviewing and analyzing the manufacturability and costs associated with CNC machining submitted by our builders. In this role, you’ll also be using your Mechanical Engineering background and knowledge of manufacturing processes in order to determine what design changes may need to be made to our builders’ design specifications in order to meet their needs. By developing highly competitive proposals and quotations that meet the requirements called out by our customers, you will be assisting in bringing products to market faster in a wide range of industries (and helping to accelerate Fictiv’s growth)

You will report to the Costing and DFM lead.

What You’ll Be Doing

1. Package review - Study the package provided by Sales to determine scope of work, manufacturing feasibility & Lead time details
2. Should be able to define best suited manufacturing process, machine selection, cycle time calculations & setup costs
3. Should be able to generate Should cost using in house calculators & Fictiv's software recommendations
4. Manufacturing Partners quote scrutiny. To check whether the provided quote is correct in terms of optimized raw material, machining & secondary processes costs
5. Should be able to negotiate with Manufacturing partners on quotes provided and get the best costs out to ensure a win win situation
6. Should be able to understand secondary process eg Anodising, Zinc plating, Chemical conversion coatings with respect to their type, class, service class, methods etc 
7. Preparing RFQ package to Manufacturing Partners referring to capability & capacity plans 
8. Calculator Generations - Use own machining expertise & understanding of process cost drivers to develop cost calculators
9. DFx Feedback - Should be able to study the 3D Model, 2D prints to determine the manufacturability of the part & highlight key points that involve a design change recommendation
10. Automation Feedback - Provide feedback to Quoting SOftware team to improve accuracy of automated quoting of our manufacturing services
11. Packaging costs - Should be able to develop packaging concept & provide the same to Logistics team for generating Shipping costs
12. Follow up with Sales for Quoted RFQ's feedback on weekly basis & also provide feedback to Manufacturing partners about quoted RFQ's status
13. Work with CFT in evaluating value deals for project management validation, project de risking, quality documentation
14. Should be able to handle Assembly product structure
15. Help clear technical queries during MP Quoting
16. Maintaining reports  for Opportunities quoted won/lost, conversion ratio etc
17. Participate in Manufacturing Partners QBR with CFT to address cost issues, conversion ratios etc

Desired Traits

1. 6-8 years of relevant work experience
2. Meticulous, detail oriented, inclination for documentation
3. Excellent verbal and written communication skills in English required
4. Self-starter, manages time efficiently, able to complete work in a timely manner without active supervision
5. Enjoys sharing knowledge and teaching others about manufacturing processes
6. 4-year Mechanical Engineering degree 
7. 3D model & 2D print review with good proofreading capabilities
8.  5, 4, 3 Axis Milling, Turn Milling,  Grinding, Gear hobbing, Spark & wire EDM, Gun Drilling processes
9. Strong GD & T background
10. CNC machines specifications/technical data
11. CNC programming for milling & turning
12. Turning & Rotating tools selection , grades of inserts for turning & Milling, Insert specification
13. Work holding devices for CNC Turning & Milling centers
14. Recommended cutting conditions for work materials classified by ISO
15. Materials (Chemical compositions, Mechanical & Thermal properties) : Stainless steel, carbon steel, alloy steel, aluminum alloys, Tool steel Titanium plastics and their associated ASTM, ISO, IS, DIN &  MIL standards.
16. Heat treatment : Normalizing, Tempering, Annealing, Case hardening, & Quenching
17. Secondary processes : Anodising, chemical conversion coatings, Zinc plating, Nickel plating, tin plating, Bead blasting & their associated standards eg MIL , ASTM , ISO 
18. Secondary processes : Painting & Powder coating
19. Inspection instruments & methods to help improve DFM feedback
20. PPAP documentation
21. ISO 9001 : 2015 Documentation
22. AS9100D documentation
23. Proficient written & oral communication skills
24. Excel & Google sheet expertise
25. Undergone training on cutting tools through Sandvik, Kennametal etc
26. Production costing background
27. Packaging estimation : concept to development

Interested in learning more?  We look forward to hearing from you soon.

Opportunity To Unlock Your Creativity
Think of all the times you were held back from trying new ideas because you were boxed in by bureaucratic legacy processes or old school tactics. Having a growth mindset is deeply ingrained into our company culture since day 1 so Fictiv is an environment where you have the creative liberty and support of the team to try big bold ideas to achieve our sales and customer goals.

Opportunity To Grow Your Career
At Fictiv, you'll be surrounded by supportive teammates who will push you to be your best through their curiosity and passion.

Impact In This Role

Your role as a Manufacturing Engineer will be to support and drive improvement to our critical manufacturing functions. We have two sets of customers—our builders, who order parts through us, and our manufacturing partners, who manufacture and assemble these parts—and you’ll be consistently working at the interface between the two. At Fictiv, we believe in creating the world’s premier platform for hardware manufacturing, and you’ll be playing a critical role in making that happen
In your role as the Manufacturing Engineer, you will be reviewing and analysing the manufacturability and costs associated with fabrication (including CNC machining, 3D printing, and other manufacturing processes) submitted by our builders. In this role, you’ll also be using your Mechanical Engineering background and knowledge of manufacturing processes in order to determine what design changes may need to be made to our builders’ design specifications in order to meet their needs. By developing highly competitive proposals and quotations that meet the requirements called out by our customers, you will be assisting in bringing products to market faster in a wide range of industries (and helping to accelerate Fictiv’s growth).
You will be reporting to the Director of Manufacturing Engineering (US) & Global Standards.

What You’ll Be Doing

• Release Package Review – Analyze models, drawings, parts lists, and other data to determine scope of work, feasibility for manufacturing, manufacturing requirements, and minimum lead time.
  
• Quoting – Combine your analysis with Fictiv’s software recommendations to generate quotes for builders, or collaborate with external suppliers to determine necessary quoting parameters.
  
• Calculator Generation – Use your fabrication expertise and understanding of process cost drivers to develop cost calculators that allow for Fictiv to bring quoting in-house for new service offerings.
  
• DFx Feedback – Provides DFx feedback to builders, such as recommended design alterations to improve manufacturability, reduce cost of part fabrication, or improve ease of assembly.
  
• Automation Feedback – Provide feedback to the quoting software team to improve accuracy of automated quoting of our manufacturing services.
  
• Drawing Generation – Generation of high-quality 2D drawings per ANSI/ASME Y14.5 standards.

Desired Traits

• Meticulous, detail oriented, inclination for documentation
• Excellent verbal and written communication skills in English required
• Self-starter, manages time efficiently, able to complete work in a timely manner without active supervision
• Enjoys sharing knowledge and teaching others about manufacturing processes
• 4-year Mechanical Engineering degree or equivalent technical training
• Understanding of GD&T and conventional (coordinate) tolerancing
• Knowledge of manufacturability, and limitations, of common metals and plastics
• Exposure to multiple custom mechanical manufacturing processes (sheet metal, urethane casting, injection molding, etc…)
• CNC machining and 3D printing experience is a must

Perks and Benefits

• Provident Fund
• Group Personal Accident Policy
  
• Mediclaim 
• And much, much more!

Interested in learning more?  We look forward to hearing from you soon.

What’s in it for you?

Opportunity To Unlock Your Creativity
Think of all the times you were held back from trying new ideas because you were boxed in by bureaucratic legacy processes or old school tactics. Having a growth mindset is deeply ingrained into our company culture since day 1 so Fictiv is an environment where you have the creative liberty and support of the team to try big bold ideas to achieve our sales and customer goals.

Opportunity To Grow Your Career
There are plenty of jobs out there. The question is whether any of them will help you grow in your career? Will you be challenged by teammates to achieve your potential? Or are they roles that will ask you to do more of what you’ve already mastered. At Fictiv, you’ll be surrounded by supportive teammates who will push you to be your best through their curiosity and passion.

Impact In This Role
Fictiv is a fast growing start-up based in San-Francisco, California - it was founded in 2013 and is revolutionising the $13 trillion manufacturing industry with a cloud-based, AI-powered platform. Fictiv’s software driven approach to manufacturing simplifies and accelerates the entire product development cycle, from prototype to production. The Fictiv Digital Manufacturing Ecosystem pairs intelligent workflow and collaboration software with a global network of highly vetted manufacturers. Fictiv’s combination of an easy-to-use cloud platform; design, quoting, billing and logistics systems; and an intelligent orchestration engine that manages our manufacturing partner network helps deliver high-quality mechanical parts at unprecedented speeds. At a time when manufacturing has become more global but remains rooted in outdated and time-intensive processes, Fictiv’s modern approach has proven to be a disruptive force in hardware manufacturing. Embraced as a trusted partner, Fictiv is transforming the way in which Silicon Valley innovators in electric and autonomous automobiles, medical robotics and consumer electronics deliver the next generation of products.

Fictiv is expanding it’s engineering team in Pune, India - we are looking for talented engineers to join us in building a highly available, performant system that scales globally with our fast-growing business.

What You’ll Be Doing

• Technical expertise – You are fluent in writing code, and possess a solid understanding of the technical domain and concepts. You have some experience in building highly available, business critical systems in cloud environments (AWS ecosystem preferred) using Node.js.
• Delivery – You consistently deliver high quality, maintainable, and defect-free code. You believe testing is an important part of creating quality software. Given an approach, you are able to deliver high quality, maintainable work (including code, tests, and documentation) without further assistance.
• Collaboration – You work well with adjacent teams and stakeholders to clarify understanding and solve problems. You proactively communicate the status of tasks and the impact on the project. You actively participate in technical design reviews and discussions.
• Team-oriented – You have a strong desire to help the team improve our collective craft. You assist in debugging production issues and handling blockers, even if you didn’t cause the problem.

Desired Traits

Your skills include -
- 3+ years of relevant experience
- Tech Stack: Node.js, JavaScript / TypeScript, GraphQL, and AWS services such as SQS, Lambdas, EC2 and RDS
- Proficiency with building backend APIs and integrations
- Experience and willingness to write unit and integration tests
- Experience developing/versioning/maintaining REST or GraphQL APIs
- Experience with SQL & No-SQL databases
- Experience with event systems such as queues, iPaaS, event buses
- Experience with distributed systems / caching / security (OWASP Top 10) is a strong plus

Interested in learning more? We look forward to hearing from you soon.

Job Summary:

We are seeking a Risk Management Project Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 1-3 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint
• Onsite job requirement in Indianapolis, IN

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Job Summary:

We are seeking a Risk Management Engineer to support the IDM Risk Management Turbo AC team. This role will support creation and continuous improvement of risk management deliverables aligned with ISO 14971 in the Turbo AC software, assist with migration of FMEAs from existing Software, and serve as an SME of the Turbo AC Software System.

You will play a key role in collaborating across engineering, manufacturing, quality, and human factors teams to ensure the setup and structure of the FMEAs are accurate to Client SOPs and ISO 14971.

Key Responsibilities:

• Support the development and deployment of risk management deliverables in alignment with ISO 14971
• Serve as subject matter expert for the Turbo AC Software System
• Facilitate and author the migration activities of FMEAs from an existing Software System into Turbo AC
• Conduct working sessions to guide teams on how to use the Turbo AC Software System
• Document bugs and tangible upgrade features to share with the Turbo AC Development team
• Creating and Running test scripts to support Turbo AC upgrade Validation
• Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design
• Create/update standard operating procedures

Qualifications:

• Bachelor’s degree in engineering, biomedical, systems, or related field
• 3-5 years of experience in medical device development or risk management
• Knowledge of ISO 14971
• Experience creating and reviewing FMEAs and other risk tools
• Strong organizational and communication skills, especially in cross-functional settings
• Proficiency with Microsoft Office tools such as Excel, PowerPoint

Nice to Have Skills:

• Experience with risk management tools like TurboAC or QMSpace
• Familiarity with the design control processes under FDA and EU MDR frameworks
• Experience with Change Control Trackwise or Veeva OneQMS

Position Overview

We are looking for Hardware Engineers to help build and maintain our robotic systems. You will be responsible for designing, developing, and testing hardware systems that integrate mechanical as well as electrical components. You will work closely with cross-functional teams to ensure our products achieve the highest standards of performance, reliability, and efficiency.

Responsibilities

• Design and develop hardware systems, including circuit boards, processors, and mechanical assemblies.
• Create detailed CAD models and drawings for jigs, fixtures, and tools using SolidWorks or other CAD software for mechanical components.
• Utilize 3D printing and rapid prototyping techniques to develop and test hardware prototypes.
• Collaborate with software engineers, mechanical engineers, and other team members to integrate hardware with software and mechanical designs.
• Conduct tests and simulations to ensure the functionality and reliability of hardware systems.
• Troubleshoot and resolve hardware issues and provide technical support during the product development lifecycle.
• Prepare documentation for hardware designs, specifications, and test procedures.

Preferred Qualifications

• BS, MS or higher degree in Computer Science, Robotics, Engineering or a related field, or equivalent practical experience.
• Proven experience in hardware design and development, including both electrical and mechanical components.
• Proficiency in SolidWorks or other CAD software for mechanical design.
• Experience with Arduino or similar platforms for electronic prototyping and control systems.
• Familiarity with 3D printing and rapid prototyping techniques.
• Strong understanding of electronic components, circuit design, and signal processing.
• Experience with testing and debugging hardware systems.

We are looking for an Application Engineer to support our Sales and Engineering teams. In this role, you will analyze CAD models and technical drawings, assess manufacturability, calculate costs, and provide DFM feedback to ensure accurate and timely quoting for our customers. This position combines deep technical expertise in manufacturing processes with strong analytical and communication skills.

Responsibilities:

• Analyze drawings and CAD models (in English)
• Calculate manufacturing costs (materials, machining hours, post-processing)
• Provide recommendations on manufacturing processes where needed
• Document and transfer calculations to the Sales/Commercial team
• Review 3D models and 2D drawings for quoting and manufacturability feedback
• Organize RFQs and clarify details with Sales and Engineering teams
• Maintain quote databases and ensure timely updates
• Deliver high-quality and accurate quotes ideally within 1–2 working hours
• Support process automation initiatives and workflow optimization

Requirements:

• Bachelor’s degree in Mechanical, Manufacturing, or Process Engineering, or a related technical field
• 5+ years of experience in metalworking / mechanical engineering
• Expert knowledge of machining and fabrication processes: turning, milling, CNC machining, EDM, laser/waterjet/plasma cutting, sheet metal processing, welding
• Understanding of post-processing methods: polishing, hardening, heat treatment, anodizing, sand/shot blasting, coatings, painting
• Knowledge of different materials (metals, plastics, composites) and their processing properties
• English level B2+
• Customer-oriented mindset and ability to clearly explain technical details
• Strong attention to detail and ability to work under time pressure
• IT-enthusiast, ready to adopt modern tools and software (CAD/CAM, CRM, cloud systems)

Core Technical Expertise:

• Technical drawing interpretation – proficiency 5/5
• Tooling & fixture design for machining, assembly, and welding – proficiency 3/5
• Manufacturing processes expertise: laser/waterjet cutting, turning, milling, grinding, EDM, sheet metal fabrication – proficiency 5/5
• Coatings and heat treatment – proficiency 3/5
• Labor intensity and manufacturability assessment – proficiency 5/5
• CAM programming for CNC (SolidWorks, Fusion 360, CypCut) – proficiency 3/5, with readiness for further training

Work Conditions:

• 3 days/week in office
• First 3 months on hybrid shift, then shifting to day shift

#LI-Hybrid

Principal Duties / Responsibilities:

· Promotes and adheres to the ATS safety culture.

· Identifies top potential issues leading to lost production and preventable maintenance spending. Communicates findings with leadership.

· Provides solutions to root cause deficiencies and demonstrates economic benefits to their correction.

· Actively drives the implementation of equipment improvement projects.

· Identifies and implements current and new processes / technologies to increase equipment performance and uptime

· Champions systems and best practice procedures towards a proactive manufacturing culture.

· Analyzes equipment performance, failure data, and corrective maintenance history to develop and deploy engineering solutions, improved maintenance strategies, preventative maintenance optimization, and other reliability techniques.

· Provides technical service to operations and manufacturing personnel on equipment related troubleshooting efforts.

· Utilizes predictive, preventative, and precision maintenance technologies and strategies designed to identify or control risks prior to failure and ensure optimum maintenance execution.

· Collaborates with the maintenance team to prioritize assets and actions by determining failure probabilities and evaluating the risk of compliance, supply, strategy, and cost.

· Provides training and coaching in ATS Root Cause and Reliability Analysis and takes ownership for ongoing corrective action tracking, implementation and follow up to ensure that all Root Cause Analysis projects are documented.

· Ensures compliance with regulatory requirements and ATS policies and procedures.

Knowledge, Skills, Abilities (KSAs), & Competencies:

Essential KSAs:

· Bachelor’s degree in engineering (ABET accredited)

· Minimum of five years of reliability experience

· Demonstrates ability to perform full array of reliability tool sets

· Strong technical understanding of electrical or mechanical components, tools, and designs

· Ability to complete a failure mode effects analysis, cause and effect diagrams, root cause failure analysis, life-cycle costing, and risk analysis

· Ability to research and apply new equipment technology / trends

· Robust problem solving, mathematical, analytical, and decision making skills

· Proficiency with computers, maintenance systems, and applications, including Microsoft Office

· Excellent verbal communication, facilitation, and presentation skills

· Strong reporting and technical writing capability

· Ability to build and maintain positive, professional relationships

Desirable KSAs

· Desire to develop into a leadership role

· Experience with data trend analysis, vibration analysis, motor current analysis, oil analysis, lubrication and hydraulic testing, laser alignment, nondestructive testing, infrared thermography, ultrasound technology, acoustic reliability technology, Weibull analysis, and Six Sigma or Lean Manufacturing methodologies

· Knowledge of various government regulations such as, Current Good Manufacturing Practice (cGMP), National Electrical Testing Association (NETA), Environmental Protection Agency (EPA), and Occupational Safety and Health Administration (OSHA)

· CMRP certification

· Green Belt certification

· STS certification

Competencies:

· Drive & Motivation

· Interpersonal Skills

· Task Management

· Strategic Skills

· Customer Focus

· Self-awareness

· Management & Leadership

ATS believes in fair and equitable pay. Please note that actual salaries may vary within the range, or be above or below the range, based on factors including, but not limited to, education, training, experience, professional achievement, business need, and location. We also offer market leading benefit programs including Medical, Dental and Vision plans, PTO, a 401k retirement plans with employer matching, tuition reimbursement, and more.

Pay Range

$106,132 - $119,718

ATS is committed to providing equal employment opportunities in all aspects of employment to all applicants and employees without regard to age, color, race, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, veteran status, genetic information, or other legally protected status. Review the privacy policy here.

ATS se compromete a brindar igualdad de oportunidades de empleo en todos los aspectos del empleo a todos los solicitantes y empleados, independientemente de su edad, color, raza, religión, sexo (incluido el embarazo, identidad de género y orientación sexual), origen nacional, discapacidad, estatus de veterano, información genética u otro estatus legalmente protegido. Revisión de la política de privacidad aquí here.

Physical Demands and Working Conditions:

While performing the duties of this job, the employee is regularly required to stand; walk; use hands/fingers to handle, or feel; reach with hands and arms; climb, ascend/descend or balance to heights that may require a ladder or lift; stoop, kneel, crouch, or crawl in confined spaces; and talk or hear. The employee is occasionally required to sit. The employee must occasionally lift and/or move more than 50 pounds. The employee is regularly required to use close vision and color vision. The employee is occasionally exposed to outside weather conditions and risk of electrical shock. Work is typically performed in a factory environment and is usually very loud. In the factory environment, the employee may be exposed to hazardous materials and/or greasy or slippery factory floors.

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ATS is committed to providing equal employment opportunities in all aspects of employment to all applicants and employees without regard to age, color, race, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, veteran status, genetic information, or other legally protected status. Review the privacy policy here.

About Tracelink:

Digital information sharing is the future of medicine. TraceLink is building the first-ever cloud-based network and application platform that helps our global customers share crucial business information while collaborating on manufacturing and distributing billions of medical products worldwide.

Tracelink is looking for talented full-time software engineers to build products at one of the fastest-growing companies in the Pune area. If you’re self-motivated, intellectually curious, and motivated by designing and developing innovative products for global organizations, you could be a good fit for our team

Who you are:

Tracelink is looking for talented full-time software engineers to build products at one of the fastest-growing

companies in the Pune area. If you’re self-motivated, intellectually curious and motivated by designing and

developing innovative products for global organizations, you could be a good fit for our team.

This is an excellent opportunity to learn and/or extend your knowledge in building large-scale multi-agent systems, define effective strategies for evaluating such systems, and gain hands-on experience in creating and testing non-deterministic software components.

Responsibilities:

The Software Development Engineer in Test assists in building and executing automated tests for the Company's

software products. The SDET will build testing tools to enable automated testing of the TraceLink platform

and application.

• Build and execute tests on the Tracelink platform and application.

• Build and deploy services for automated testing of the Tracelink platform persistent store.

• Execute performance tests on a Distributed Persistent Data store

• Create testing tools that can simulate real-world transaction volumes.

• Provide high-level analysis to apply appropriate technologies and architecture to solve conceptual problems

• Stay curious, build Innovative solution to new age technical issues

• Influence designs and decision with supporting data

• Work closely with engineers building the core Tracelink product to ensure that testability concerns are factored into the design of the product.

• Extend and maintain automation frameworks to enhance Test coverage

• Prepare and present clear reports on defect findings that allow developers to reproduce problems and allow the Quality Engineering team to verify that fixes are complete quickly and accurately.

• Programmatically interface testing tools with the TraceLink platform and application.

• Work closely with engineers building the core TraceLink product to ensure that testability concerns are factored into the design of the product.

• Research and remain informed of new technology and tools, and how such technologies could be applied at Tracelink.

Qualifications:

Candidates must possess the following skills and traits:

• Bachelor's degree or foreign equivalent in computer science, software engineering, mechanical engineering, or related discipline.

• 5-8 years of progressive, post-baccalaureate experience in a test automation engineering role involving programmatic interaction with a system under test.

• Experience utilizing Java, JavaScript/TypeScript, Eclipse, Ant or Maven, Unix, and an automated unit test framework, such as TestNG.

• Experience developing against web services and Web-based APIs.

• Experience developing and executing formal test plans, data sets, and test configurations for assigned feature areas.

Helpful skills and experience:

• Familiarity with the concepts involved in running cloud-based applications on platforms such as Amazon Web Services.

•  Experience with the pharmaceutical industry.

•  Basic understanding of Large Language Models (LLMs) and generative AI systems.

•  Exposure to testing LLM-based applications, including prompt validation and response evaluation.

•  Familiarity with multi-agent LLM workflows and coordination patterns (e.g., agent orchestration, tool usage, chaining).

•  Experience designing test scenarios for AI systems, including edge cases, hallucination detection, and output consistency checks.

•  Knowledge of evaluation metrics for LLM outputs (e.g., accuracy, relevance, latency, and robustness).

•  Exposure to automation frameworks or tools for validating AI/ML model behavior.

Responsibilities:

Entry level CQV Engineer position in the Pharma industry. Client will train the resource on Deviation Investigation.

Requirements

• Deviation investigation remediation experience is a plus but is not necessary.
• Undergraduate Engineering/STEM degree preferred (mechanical, chemical, biomedical, etc.).
• 0-3 years experience. Some Pharma experience preferred but not absolutely required. New college grads with internship experience encouraged to apply
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail
• Strong interpersonal skills and clear communication capabilities.
• Experience with and tolerance for high levels of challenge and change.