We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
• Ensure deviations are thoroughly documented, investigated, and closed within required timelines
• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support validation impact assessments and execution activities related to changes
• Review and approve validation and technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
  • Change control systems
  • Deviation investigations and root cause analysis
  • cGMP and GDP environments
• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

Job Introduction: We are seeking an experienced Senior Program Manager to lead the delivery and implementation of critical manufacturing and quality systems, including MES, CSV, and EMS, within a fast-paced, high-visibility pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can drive execution across cross-functional teams, proactively manage risk and ambiguity, and ensure projects are delivered on time, with quality, compliance, and strong stakeholder alignment.

Senior Program Manager Responsibilities:

• Lead end-to-end project delivery across MES, CSV, and EMS initiatives
• Manage project scope, schedule, budget, risks, and dependencies
• Drive coordination between IT, Quality, Manufacturing, and external vendors
• Ensure all systems and processes align with GxP and regulatory expectations
• Oversee validation activities, including planning, execution, and documentation
• Facilitate issue resolution and decision-making across stakeholders
• Provide clear and consistent status reporting to leadership
• Support integration efforts across manufacturing and enterprise systems
• Maintain strong governance and change control throughout the project lifecycle

Job Requirements:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical), Project Management, or related technical field
• 7–12+ years of project management experience in life sciences or regulated industries
• Proven experience delivering MES implementations (e.g., PAS-X, Syncade, Opcenter, etc.)
• Strong background in CSV and validation methodologies (CSA preferred)
• Experience with EMS platforms and integration into manufacturing environments
• Experience with SAP and other Enterprise platforms
• Demonstrated ability to operate in fast-paced, high-pressure environments
• Strong stakeholder management and communication skills
• Experience managing vendors and system integrators
• Familiarity with GxP, 21 CFR Part 11, and data integrity requirements
• Experience supporting greenfield or startup manufacturing environments preferred
• Exposure to biologics, cell and gene therapy, or similar advanced modalities preferred
• PMP or equivalent certification preferred
  

Systems Engineer Responsibilities:

• Requirements & Traceability: Solicit, manage, and document stakeholder needs and requirements across constituent systems; perform requirements analysis, development, allocation, and management; create and maintain traceability from requirements (including system risk) to system verification and validation; manage requirements flow-down and interface requirements between constituent systems.
• Integration & Verification: Develop and document system test strategies; lead system integration, verification, and validation activities across constituent systems; participate in design reviews and contribute SE deliverables aligned with regulations and standards.
• System Design & Architecture: Develop and document system architecture including concept trade-offs, functional analysis, and interface definitions; apply systems thinking to understand how constituent systems interact within the broader product ecosystem; define and manage system boundaries and interfaces between constituent systems.
• Risk Management: Support system-level hazard identification and participate in risk identification, assessment, and management activities; collaborate on risk documentation and maintaining risk management files; apply hazard analysis techniques (FTA, FMEA) to support product safety throughout the development lifecycle.
• Continuous Improvement & Quality: Participate in the systems engineering community of practice to stay current with tools, techniques, and regulatory expectations; drive continuous process improvement focused on SE-related processes and tools; proactively identify and communicate quality issues.

Requirements:

• Bachelor’s degree in an engineering field with 5+ years of relevant experience
• Demonstrated experience creating systems engineering work products (e.g. stakeholder requirements document, system requirements document, V&V matrices, etc)
• Proficiency with requirements management
• Strong technical writing skills for protocols, reports, and regulatory submissions
• Experience with drug delivery devices (autoinjectors, pen injectors, wearables, inhalers) or combination products
• Knowledge of ISO 14971 (risk management), ISO 13485 (quality management), and FDA 21 CFR Part 820 (design controls)
• Experience with hazard analysis techniques (FTA, FMEA) and risk management activities
• Qualified candidates must be legally authorized to be employed in the United States
• Onsite job requirement in Indianapolis, IN

Project Engineer Responsibilities:

• Support execution of capital and operational projects involving process equipment such as tanks, heat exchangers, and boiler systems
• Read, interpret, and trace P&IDs to support system understanding, troubleshooting, and field execution
• Coordinate and execute line breaks, system tie-ins, and circuit modifications in active manufacturing environments
• Partner with production teams to plan and schedule equipment downtime, minimizing impact to ongoing operations
• Participate in and enforce Lockout/Tagout (LOTO) procedures to ensure safe execution of field work
• Perform hands-on field activities including system walkdowns, troubleshooting, and supporting mechanical installations/modifications
• Assist with process-related tasks including equipment improvements, optimization efforts, and minor design changes
• Collaborate cross-functionally with Maintenance, Operations, EHS, and Quality to ensure projects meet safety and compliance standards
• Support documentation updates (P&IDs, SOPs, change controls) as required
• Track project tasks, timelines, and deliverables; provide updates to stakeholders and escalate risks as needed
• Support contractors and vendors during onsite work, ensuring adherence to site procedures and expectations

Job Requirements:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, or a related technical field
• 2–5 years of experience in pharmaceutical, biotech, or regulated manufacturing environments
• Working knowledge of process equipment such as tanks, heat exchangers, and boilers
• Experience reading and working with P&IDs in a live production setting
• Familiarity with Lockout/Tagout (LOTO) and safe work practices in industrial environments
• Strong mechanical aptitude with a willingness to be hands-on in the field
• Exposure to GMP-regulated environments and working alongside Quality and Compliance teams
• Experience coordinating work during planned shutdowns or production downtime windows
• Experience acting as a project lead or supporting project management activities (scope, schedule, coordination)
• Ability to work occasional off-hours or weekend shifts to support critical project activities
• Ability to be on-site, full-time in Minster, OH

The Automation Project Manager is responsible for leading automation and IT-focused lifecycle management (LCM) and obsolescence projects across manufacturing and operational environments. This role manages end-of-service-life (EOSL) initiatives ranging from firmware updates to full control system upgrades, ensuring minimal disruption to operations while maintaining compliance with regulatory and quality standards.

Job Responsibilities:

• Lead end-to-end execution of automation lifecycle and obsolescence projects, including PLC, HMI (PanelView), SCADA, and controls system upgrades
• Manage projects ranging from minor firmware updates to full-scale control system replacements, including planning, budgeting, scheduling, and execution
• Coordinate cross-functional teams including Automation, IT, Engineering, Quality, Validation, and Operations
• Oversee vendor and system integration activities for design, development, installation, and commissioning
• Ensure all upgrades align with lifecycle management strategies, cybersecurity standards, and business continuity requirements
• Drive validation activities (as applicable), ensuring compliance with GxP, CSV, and regulatory expectations
• Develop and maintain project documentation including project plans, risk assessments, change controls, and status reports
• Identify and mitigate risks related to system obsolescence, downtime, and integration challenges
• Support shutdown planning, system cutovers, and startup activities to minimize operational impact
• Provide clear communication and reporting to stakeholders on project status, risks, and milestones

Job Requirements:

• Bachelor’s degree in Engineering, Automation, Computer Science, or related technical field
• 5+ years of project management experience in automation, controls, or IT systems within pharma/life sciences manufacturing environments
• Proven experience managing automation upgrade or obsolescence (EOSL) projects
• Strong knowledge of PLCs, HMIs (e.g., PanelView), SCADA systems, and industrial automation infrastructure
• Experience with validation processes (CSV) and regulated environments is highly preferred
• Familiarity with change control, risk management, and lifecycle management practices
• Strong leadership, communication, and stakeholder management skills
• PMP or equivalent project management certification is a plus
• Ability to be on-site, full-time in Mount Vernon, IN

The Facilities / Project Engineer will serve as a Subject Matter Expert (SME) supporting critical utility systems within a regulated pharmaceutical manufacturing environment. This role requires deep mechanical expertise, advanced troubleshooting capability, and a comprehensive understanding of both standard and clean utility systems that directly impact product quality and manufacturing operations. The ideal candidate will operate as the site authority on utilities performance, reliability, and technical problem-solving—driving continuous improvement while ensuring systems operate in a controlled and compliant state.

Job Responsibilities:

• Serve as the site SME for all facility and utility systems, including both plant utilities (HVAC, chilled water, steam, compressed air) and clean utilities (purified water, WFI, clean steam)
• Provide advanced technical support and troubleshooting for complex system issues, including rapid response to critical utility excursions impacting manufacturing
• Lead detailed root cause analyses for system failures, performance deviations, and recurring issues; implement robust, long-term corrective solutions
• Own system performance, reliability, and lifecycle strategy for assigned utilities, including capacity planning, redundancy, and risk mitigation
• Interpret and analyze system data/trends (flows, pressures, temperatures, conductivity, TOC, etc.) to proactively identify risks and optimize performance
• Act as the primary technical interface between Facilities, Manufacturing, Quality, and Engineering to ensure utility systems consistently meet operational and quality requirements
• Support and guide maintenance teams in advanced troubleshooting, repair strategies, and execution of complex mechanical work
• Review and approve technical changes, system modifications, and design updates to ensure alignment with operational needs and system integrity
• Provide technical oversight during installation, startup, and commissioning of new or upgraded utility systems, ensuring proper system functionality and performance
• Develop and enhance preventive and predictive maintenance programs tailored to critical and clean utility systems
• Ensure utilities are designed, operated, and maintained with a clear understanding of their impact on product quality and regulatory expectations
• Support regulatory inspections, audits, and internal reviews as the utilities SME, providing technical justification and system knowledge as required

Job Requirements:

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline)
• 5+ years of experience in facilities, utilities, or project engineering within a GMP-regulated industry (pharmaceutical, biotech, or similar)
• Deep technical knowledge of clean utility systems, including purified water (PW), Water for Injection (WFI), clean steam, and associated distribution systems
• Strong mechanical expertise across HVAC systems, boilers, chillers, pumps, heat exchangers, and fluid handling systems
• Proven ability to troubleshoot complex, multi-system issues and drive effective root cause resolution
• Strong understanding of how utility systems impact product quality, process consistency, and regulatory compliance
• Experience working within GMP environments, including interaction with Quality and Manufacturing organizations
• Proficiency in reading and interpreting P&IDs, mechanical drawings, and system schematics
• Familiarity with building management/automation systems (BMS/BAS) and utility monitoring systems
• Strong communication skills with the ability to translate complex technical issues into clear, actionable insights
• Ability to be on-site, full-time, in West Chester, OH

Validation/CQV Engineer Responsibilities:

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed records qualification and validation
• Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment

Requirements:

• Bachelor’s Degree or equivalent required
• 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
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Onsite work requirements in Indianapolis, IN

Facilities Project Manager Job Responsibilities:

• Lead full lifecycle capital projects with a focus on pharmaceutical utilities and facilities systems (HVAC, clean utilities, WFI, clean steam), ensuring delivery on scope, schedule, and budget
• Manage concurrent engineering projects including facility upgrades, infrastructure improvements, packaging, and inspection systems
• Provide technical leadership for GMP-regulated facility and utility projects, ensuring compliance with CQV and validation requirements
• Develop and control capital budgets and forecasts, track spend, and manage financial performance across projects
• Oversee construction activities and contractor execution (preferred), including bid evaluation, field coordination, and safety compliance
• Ensure adherence to project governance, design reviews, change control, and validation documentation (IQ/OQ/PQ)
• Collaborate cross-functionally with Facilities, Manufacturing, Quality, Validation, and EHS to support site readiness and operational reliability
• Manage external vendors, contractors, and engineering firms to ensure quality, safety, and timely project delivery

Job Requirements:

• Bachelor’s degree in Engineering required; strong project scheduling, budgeting, and leadership skills expected
• 7–10+ years of experience in pharmaceutical/biotech environments with a focus on utilities, facilities, and capital projects
• Advanced proficiency with Microsoft Project or similar tools for complex project scheduling
• Strong experience in capital budgeting, forecasting, and cost control, particularly for facility and construction projects
• Strong knowledge of GMP requirements and equipment qualification
• Deep understanding of pharmaceutical utility systems (HVAC, clean rooms, WFI, clean steam, process gases, building management systems)
• Experience with facility design, equipment layout, and infrastructure integration
• Knowledge of GMP requirements, equipment qualification (IQ/OQ/PQ), and validation lifecycle
• 100% on-site presence required (Newark, DE)
  

Lead Process Engineer Responsibilities:

• Lead and execute Design of Experiments (DOE) studies to evaluate and optimize pharmaceutical manufacturing and packaging processes
• Provide technical leadership for process improvement initiatives, focusing on efficiency, reliability, and product quality
• Support and optimize liquid/gel filling and bottle/tube packaging operations within pharmaceutical manufacturing environments
• Conduct root cause investigations for process deviations or performance issues and implement sustainable corrective actions
• Collaborate with cross-functional teams including manufacturing, quality, and engineering to support process development and improvement efforts
• Serve as a client-facing technical expert, working directly on-site with customers and stakeholders to address process challenges
• Document process studies, experimental results, and improvement initiatives in accordance with industry and company standards

Job Requirements:

• Bachelor’s or Master’s degree in Chemical Engineering
• 5–10+ years of experience in the pharmaceutical industry supporting manufacturing or process engineering
• Minimum 5 years of hands-on experience designing and executing DOE (Design of Experiments) studies
• Demonstrated experience supporting liquid/gel filling and bottle/tube packaging processes
• Strong analytical and problem-solving skills with experience performing root cause analysis and implementing process improvements
• Ability to work on-site 75%+ of the time

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

Complaint Investigator / Quality Specialist Responsibilities:

• Review and investigate complaint information provided
• Perform visual/functional assessment as required
• Utilize TrackWise to record and document Complaint History
• Research Deviation, Batch Record Review, Design History File/FMEA Review, Product Safety Assessment and Product Impact Evaluation background information pertaining to complaint
• Contact data stewards in order to gain more insight into complaint and gather data as needed
• Utilize Root Cause Investigation Summary and CAPA Overview as necessary to inform investigation
• Author Templates for basic complaints and complex complaints
• Utilize Templates to expedite the investigation write-up process for future complaint investigations

Requirements:

• Demonstrated capability to deliver on the Quality Specialist Responsibilities
• Capacity to make independent sound decisions and independently manage priorities
• Demonstrated ability to generate high-quality project deliverables independently by required due dates
• Capacity to identify issues and proactively elevate to the project lead
• Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
• Minimum 2 years of role relevant experience

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

Senior Automation Engineer Responsibilities:

• Automation Engineer strong in IT/IT-centric systems to help with troubleshooting, detecting issues
• Responsible for design and implementation of key automation aspects of an equipment project, often including PLC, vision, HMI programming.
• General Change management
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Independent verification of testing against specifications
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
• Running test scripts and documenting results.
• Adherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation
• Documenting impact and risk assessments as part of a team.
• Design and PLC programming (configuration of PLC program) on standard equipment/products
• Lead and perform complex quality checks which require an intricate understanding of the machine control systems and operations
• Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams
• Contribute to the completion of projects, manage own time on agreed targets, develop plans for own projects and leads small project teams
• Monitor, generate and complete the periodic review, validation master plan for the automation engineering program
• Demonstrate good planning, organizing, time management and team participation skills
• Responsible for routine and preventive maintenance work, ensure all the equipment and facilities work safely, efficiently and reliably
• Generate and develop standard operating procedures and system support
• Analyze operational process problems and recommend appropriate corrective and preventative actions
• Manage change control authoring and execution
• Participate in the site and network wide teams to provide cybersecurity alignment and direction
• Provide 24x7x365 support of automation systems and perform automation activities for capital and non-capital projects
• Modify moderately complex to highly complex control logic that requires a degree of scientific and/or manufacturing process expertise
• Clearly communicate progress and issues to peers

Requirements:

• Must have 3-5 years of industrial experience as an Automation Engineer
• Experience in creating SQL databases
• Understanding domain authentication
• Experience in working with IT to schedule implementations
• Able to complete software installs and/or updates
• Creation of databases
• Experience in upgrading system requirements for servers
• Understanding of Citrix application
• GMP and Good Documentation Practice knowledge
• Position requires onsite work in Indianapolis, IN
• Responsible for installing, maintaining, and troubleshooting automated utility, processing, filling, inspection, and packaging equipment
• Generate user requirement specifications for control systems
• Able to make minor modifications to code and HMI graphics for smaller changes
• Must be able to read logic and perform programming as well as update control system documentation
• Contribute technical content to validation protocols on automation systems and perform execution of protocols

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