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Freudenberg Medical · 5 days ago

Senior NPI Engineer

Minnetonka, MN

Full-time

Onsite

Senior Level, Lead/Staff

$110K/yr - $140K/yr

8+ years exp

Freudenberg Medical is a global technology group focused on delivering high-quality solutions for medical device and pharmaceutical companies. The Senior NPI Engineer will lead and manage new product introduction projects, ensuring compliance with regulatory standards and collaborating with cross-functional teams to drive the design and development of new medical devices.

ManufacturingMedical Device

No H1B

Responsibilities

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

Qualification

NPI processMedical device experienceRegulatory complianceProcess validationISO standardsGMP principlesStatistical process controlTechnical documentationProblem-solving skillsTeam leadership

Required

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 knowledge of manufacturing equipment and automation systems, and the ability to optimize their utilization

Understanding of advanced manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing and assembly, including the materials used

Advanced understanding of ISO standards. Extensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements

Expertise in leading process validation and verification efforts to ensure consistent product quality and compliance with regulatory standards and necessary safety protocols

Advanced knowledge of quality control tools such as statistical process control (SPC) and root cause analysis

Strong knowledge of product testing and inspection methods, including developing test protocols and overseeing testing activities to ensure compliance with specifications and standards

Ability to create and maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records

Deep understanding of the NPI process and ability to lead the introduction of new products into the manufacturing environment and advanced problem-solving skills to identify and resolve issues that may arise during manufacturing process

Benefits

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.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off.