About The Team 

Noah Medical is recruiting for a Product Support Engineer to facilitate operational and service engineering support of Noah medical products and digital platforms. The Product Support Engineer serves as a primary liaison between Noah’s internal technical groups (Engineering, Quality, Manufacturing) and the various internal and external departments supporting Service (Field and Customer Service, Clinical Sales, and Marketing). 

The role should expect to travel within the United States up to 25% of the time. This travel may include customer visits, managing escalations, team meetings, attending conferences, or other activities to support the business. 

 A Day In the Life of a Product Support Engineer 

• Provide real-time troubleshooting support for escalations from internal customers (Field Service, Sales & Marketing) 

• Serve as a primary technical liaison between Noah Medical and commercial partners, distributors, and key customer accounts, building strong relationships and driving customer satisfaction and retention 

• Apply strong problem solving skills to complex product and process challenges; lead and collaborate cross-functionally including with commercial teams and distribution partners to drive resolutions that minimize customer impact 

• Drive complex failure investigations, data collection and analysis, and collaborate closely with the engineering team to identify product design, service, and quality improvement opportunities. 

• Develop & maintain service procedures, service bulletins, risk assessment documents, training materials, knowledge base articles. 

• Develop validation protocols and reports for internal service processes  

• Develop, manage, and drive continuous improvement in field tooling (hardware, software, and infrastructure tools) 

• Provide technical support for Quality and Post-Market activities including CAPAs, field actions, and complaint investigations, ensuring commercial impact is assessed and communicated 

• Ensure customer feedback is documented, analyzed, and used to drive improvements in service delivery. 

 About You 

• Bachelor’s degree in Engineering (Electrical, Electronics, Mechanical, or Fluidics), and/or at least 3 years of relevant experience.  

• Relevant clinical or bronchoscopy engineering experience including, but not limited to, understanding of basic pulmonary anatomy and physiology 

• Relevant Experience with system/electrical troubleshooting, detail-oriented and willing to find the root causes of issues with good engineering practice 

• Excellent oral (including group presentations) and written communication skills, as well as solid organizational and time management abilities 

• Self-motivated and proactive, with a passion for quality and continuous improvement 

• Live in the assigned geography 

• Willing to travel and be hands-on in the field to service the product whenever necessary. 

• Must be fiscally responsible, able to make own travel arrangements, and turn in expense reports on a weekly basis. 

• Excellent computer and technology skills with regards to software applications, (Excel, Word, Outlook, Power Point) ERP databases, and technology innovation. 

• Must have a valid driver’s license.

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About The Team

We are seeking a skilled Test Technician to join our team. The ideal candidate will be responsible for testing and troubleshooting medical robotic systems while adhering to Good Manufacturing Practices (GMP). The successful candidate will have a strong understanding of robotic hardware, sensors, motors, PLC’s, relays, circuit boards, computers, cabling and experience with and testing, excellent troubleshooting skills, and GMP experience.

A Day In The Life Of Our Manufacturing System Technician

• Assemble and/or test medical robotic systems according to established MPI, drawings, and schematics.
• Assemble and/or test medical subassemblies according to established MPI, drawings, and schematics.
• Perform packaging medical subassemblies and systems according to established MPI, and drawings.
• Install and configure hardware components, including robotic arms, sensors, motors, PLC’s, relays, circuit boards and cables.
• Install and configure software components, including programming and testing of robotic movements and functions.
• Perform system testing and work with engineers to troubleshoot issues as they arise.
• Collaborate with other team members to identify and resolve issues.
• Assist with inventory management and point out shortages as needed.
• Maintain accurate records of system configurations, test results, and troubleshooting activities as part of the Device History Records while adhering to GMP.
• Maintain a clean and organized work area as part of the line clearance procedure as lean manufacturing practices.
• Meet all standard cycle time requirements and quality standards.
• Perform other reasonable duties in assembly, rework, or test as required
• Might require to stay overtime as required
• Shift schedule: Monday - Thursday: 5:00AM-3:30PM

About You

• High School Diploma required and a Minimum 3-5 years of medical device test work experience required (or)
• AS Degree in Computer Science and minimum 2 years of testing Medical Device experience (or)
• BS in Computer Science, Electrical Engineering, or Industrial Engineering with 1 year of experience medical device test work experience
• English language proficiency required
• Knowledge of working Microsoft office and other PC software
• Knowledge of GMP, Non-Conformance reports, and Line clearance experience required.
• Work with the production manager and engineers to assist root cause analysis for nonconformance.

Experience working in a regulated environment in compliance with ISO 13485 and 21 CFR 820 required.

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About The Team

The Senior Facilities Technician will be a key contributor to various projects in our growing company.  You have experience supporting multiple buildings with facilities maintenance, repairs, improvements, and expansions.  You have experience in areas such as electrical, plumbing, carpentry, construction. You are able to prioritize and multi-task effectively in an agile, start-up environment and are able to collaborate with cross functional teams and vendors.  

A Day In The Life Of Our Sr. Facilities Technician at Noah Medical

• Assist with the coordination and execution of facility improvements, expansions, and maintenance. This may include electrical work, plumbing, carpentry, ventilation, painting, heating/cooling, and other building related tasks. 

• Assist with installation and modification of production workstations, clean rooms, and material handling systems. 

• Inspect lighting and fixtures to ensure adherence to code and modify as necessary. 

• Install, maintain, and troubleshoot equipment, utilities, and hardware.  

• Perform preventive maintenance of some production equipment. 

• Identify building safety hazards and work with vendors when needed. 

• Obtain any required facility permits for compliance. 

• Execute 5S solutions as directed by the Operations team. 

• Assist with construction and tenant improvements. Send work orders to landlord on roof leaks and exterior repairs. 

• Follow through with facility project plans and schedules.  

• Perform other reasonable facilities duties and resolve facility issues quickly while minimizing risk and properly communicate issues 

• Respond to emergency situations. 

About You

• High school diploma or possession of a G.E.D. 

• Minimum of 2 years of working experience in construction trades or facilities roles.  

• Good mechanical aptitude and the ability to work with hand and power tools 

• Basic understanding of electrical, plumbing, carpentry, painting, and construction equipment. 

• Strong team player with a demonstrated history of success working in a multi-disciplinary, cross-functional environment 

• Ability to work independently or with others during projects. 

• Must demonstrate strong communication and interpersonal skills, customer service oriented 

• Must be organized, detail oriented, self-motivated, and able to multi-task 

• Strong problem-solving skills paired with ability to be proactive and foresee next steps 

• Must have some computer skills, Microsoft Outlook, Word, Excel. Operate mobile equipment including forklift and scissor lifts in the performance of duties 

• Must be able to work flexible hours 

• Ability to handle physical workload including standing-walking, bending, kneeling, stooping, lifting up to 40 pounds, and moving objects between 10-50 pounds. 

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About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together! 

This position is responsible for ensuring product quality throughout the design lifecycle while serving as a key liaison between Engineering and the Service organization. This role drives design robustness, field performance improvement, and customer satisfaction by proactively incorporating serviceability, reliability, and field feedback into product development and continuous improvement initiatives. We are looking for someone that is highly motivated and solution oriented; you must be a self-starter, team builder, and excellent communicator. This is a 6-month contract opportunity. 

A Day In The Life Of Our Contract Sr. Design Quality Engineer-Service at Noah Medical

• Act as the primary quality liaison to the Service organization. 

• Support Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Serviceability (DFS) initiatives. 

• Review hardware and system-related verification and validation strategies for the Service organization and ensure timely execution.   

• Co-develop the project process validation strategy and review IQ/OQ/PQ/TMV protocols for service tools, equipment, software, and field processes. 

• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management. 

• Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.   

• Review test plans, and test cases based upon the product and component level requirements, ensuring that appropriate statistical techniques are applied. 

• Review and approve V&V system maintenance such as reworks and modification and tracking. 

• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action.  Use the NC and CAPA systems as needed to structure activities. 

• Support field service engineering requests and assess serviceability risks. 

• Partner with PMO to apply project management tools to define project deliverables and establish a project schedule. 

• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness. 

About You

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc. 

• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD.    

• Preferred 2 years experience in a development QE function in a regulated environment 

• Experience in meeting Design Control and DHF requirements with R&D teams. 

• Experience with Quality Management System to meet US FDA and ISO/MDR requirements. 

• Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements. 

• Experienced with statistical skills to define/train on test sample size and data analysis techniques. 

• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems. 

• Must be a self-starter, team builder, and excellent in verbal and written communication. 

• Preferred: Experience working in a clinical setting, and or field service 

• Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc 

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About The Team

The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development.  We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.

A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical

• Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones. 
• Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect. 
• Manages the RA/QA department functions through direct reports or subordinates.
• Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations. 
• Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.  
• Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
• Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions. 
• May serve as the designated Management Representative. 

About You

• Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc. 
• Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
• Minimum of 3 years of supervisory experience of multiple exempt level employees.
• Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
• Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
• Experienced in conducting internal and supplier audits and hosting 3rd party audits.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred: Knowledge of sterile/disposable medical device production processes.
• Preferred: Master Degree, MBA, experienced with Software Validation, 
• Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc. 

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