New Product Introduction Engineer II - Med Device

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. 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. Personal Development: We offer a variety of trainings to ensure you can develop in your career. Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees. Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement. Medical, Dental, and Vision Coverage; Retirement Savings with Company Match; Paid Time‑Off Candidates must be legally authorized to work in the United States without current or future visa sponsorship. Minnetonka, MN – On‑Site The expected salary range for this position is $90,000 to $105,000 annually, depending on skills, experience, and qualifications. New Product Introduction Engineer II – Med Device Responsibilities Execute the development, prototyping, and testing of new products/processes, including design verification, validation, and the creation of standard operating procedures (SOPs), test methods, and technical documentation. Support planning and executing NPI projects from concept to commercialization, ensuring timelines, budgets, and customer requirements are met. Collaborate with internal teams, customers, and suppliers to develop manufacturing processes, select materials, resolve technical issues, and support design for manufacturability. Plan and execute process validation (IQ, OQ, PQ), risk assessments (per ISO 13485), and process control strategies to support robust product and process development. Support risk management activities (i.e., PFMEA) and ensure integration and alignment with applicable regulatory standards. Provide hands‑on support for prototyping, pilot builds, process development, validation, transfer to production, and troubleshooting, and collaborate with suppliers for materials, components, and equipment qualification. Contribute to feasibility studies and evaluate new technology identification to ensure scalable, compliant manufacturing solutions. Engage in cross‑functional communication and external collaboration to align project goals, manage stakeholders, and facilitate NPI project timelines while staying current with industry technologies and best practices. Support management of QMS activities such as CAPAs, PARs, NCMRs and other applicable items as required. Qualifications Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.) or related science/technical field. 3+ years’ experience in a medical device or related industry. Understanding of relevant ISO standards, knowledge of GMP principles and their application in medical device manufacturing, including country‑specific regulatory requirements. Understanding of process validation principles and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols. Intermediate knowledge of quality control tools such as statistical process control (SPC) and root cause analysis. Familiarity with product testing and inspection methods to ensure compliance with specifications and standards. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. #J-18808-Ljbffr Freudenberg Medical