Senior Manufacturing Process Development Engineer (Operations Engineer)
Responsibilities
The Senior Manufacturing Process Development (Operations Engineer) is responsible for sustaining and improving commercial medical device manufacturing processes across internal and contract manufacturing sites. This role provides hands-on engineering support to production, leads and owns segments of root cause investigations (including NCMR and CAPA activities), executes bench testing and validation activities, and drives continuous process improvements to ensure product quality, compliance, and operational efficiency.
This individual operates in a fast-paced, cross-functional environment and plays a key role in maintaining product performance, regulatory compliance, and cost-effective manufacturing.
This role will be onsite and consist of 25% travel to various sites, within the Twin Cities and OUS. No relocation is provided and no sponsorship is available for this role.
Major Responsibilities:
• Provide daily technical support to manufacturing and contract manufacturing sites.
• Troubleshoot production issues and implement timely corrective actions.
• Leads and independently executes root cause investigations (including NCMR and CAPA activities) for customer complaints, and supplier quality issues.
• Utilize structured problem-solving methodologies (5-Why, Fishbone, statistical analysis) to identify root cause.
• Design, validate and execute bench testing to evaluate product or process performance in accordance with FDA and ISO requirements.
• Analyze data using Excel, Minitab, or similar tools and document findings in formal technical reports.
• Author and update work instructions, SOPs, test methods, validation protocols, and engineering change documentation.
• Ensure compliance with FDA Quality System Regulation (21 CFR 820) / Quality Management System Regulation (QMSR) and ISO 13485 requirements.
• Drive continuous improvement initiatives to improve yield, cost-of-goods, manufacturability, and process robustness.
• Collaborate cross-functionally with Manufacturing, Quality, Regulatory, R&D, and Supply Chain teams.
• Support product development transfers to manufacturing and scaling production activities.
• Participate in weekly operational reviews and communicate risks, challenges, and progress clearly to leadership.
• Lead cross-functional project teams for defined operations initiatives and serve as technical owner for assigned process or product families.
Qualifications
Education:
• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related engineering discipline required. **
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Experience:
• Minimum 5 years of experience in medical device manufacturing and/or process development.
• Hands-on experience supporting production in a regulated manufacturing environment.
• Demonstrated experience leading or contributing to NCMRs, CAPAs, and root cause investigations.
• Experience with manufacturing sustaining engineering and process improvement initiatives.
• Experience with catheter manufacturing processes (e.g., extrusion, braiding, bonding, reflow, molding etc.)
• Experience with polymer materials and bonding technologies.
• Experience working with contract manufacturers preferred.
• Experience supporting product transfer to manufacturing preferred.
• Experience with risk management (ISO 14971)
• Familiarity with FMEA (Design/Process/Use)
• Experience with SPC and control plans preferred
Technical Skills:
• Strong understanding of engineering fundamentals and manufacturing processes.
• Statistical knowledge and experience analyzing data sets.
• Proficient in Microsoft Office (Word, Excel required).
• Experience with Minitab or similar statistical software preferred.
• CAD experience (SolidWorks or equivalent) preferred.
• Familiarity with FDA QSR and ISO 13485 requirements.
Additional Competencies:
• Strong analytical and structured problem-solving skills.
• Clear technical writing and documentation ability.
• Ability to manage multiple priorities independently.
• Strong communication and cross-functional collaboration skills.
• Comfortable working in a fast-paced, growth-stage organization.
• Ability to travel up to 25% as needed.