Senior NPI Engineer

Senior New Product Introduction Engineer

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$/yr - $/yr

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high‑quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

• 401K Match: Save for retirement with the company's help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Performance Related Bonus: When you have an impact, you can reap the rewards.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.
• NO VISA SPONSORSHIP.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time‑off. Additional details will be shared during the recruitment process.

Minnetonka, MN

On‑Site

Freudenberg Medical LLC

• Lead and manage new product introduction (NPI) projects from concept through commercialization, including project planning, budgeting, resource management, and stakeholder communication.
• Drive the design, development, prototyping, and testing of new medical devices, ensuring compliance with customer requirements, design inputs, and applicable regulatory standards.
• Oversee design verification and validation, process validation (IQ/OQ/PQ), and test method development, ensuring robust, compliant, and scalable manufacturing processes.
• Collaborate cross‑functionally with product development, quality, manufacturing, regulatory, customers and suppliers to ensure design for manufacturability (DFM), risk management (PFMEA), and smooth design transfer to production.
• Provide technical leadership and mentoring to less experienced engineers, guiding problem‑solving, process improvements, and quality initiatives to support continuous improvement.
• May supervise a small team of Engineer I or Technician colleagues. Lead risk management activities, including the development of risk analysis, validation protocols, and quality control plans to ensure product and process compliance.
• Utilize statistical tools (DOE, SPC, Minitab) to analyze data, improve process capability, and support quality decision‑making; manage nonconformance, CAPA, and change control processes.
• Support and participate in supplier qualification, vendor assessments, customer communication, and regulatory audits while ensuring alignment with ISO, applicable regulatory and company standards.
• Support new business acquisition through the quotation process.
• Define and control production process including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment.
• Working closely with Operations team to ensure all facilities are prepared for new product launches.
• Define Capex needs for and scalability plans, including facility planning for new product launches.

• Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.), or related science/technical field.
• 8+ years’ experience in medical device or related industry experience.
• Experience in supporting regulatory submissions and managing audits related to manufacturing and NPI processes.
• Experience in integrating new technologies and innovative solutions into the manufacturing process.
• In-depth…