Sr. Product Development Engineer

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. Benefits Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success. Sustainability & Social Commitment Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement. Performance Related Bonus Performance Related Bonus: When you have an impact, you can reap the rewards. Personal Development Personal Development: We offer a variety of trainings to ensure you can develop in your career. Candidate must be legally authorized to work in the United States without current or future 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. Location: Carpinteria, CA Work Location: On-Site Salary range: $120,000 to $150,000 annually, depending on skills, experience, and qualifications. Qualifications Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field. 8+ years' experience of engineering in medical device or related industry experience. Extensive knowledge and understanding medical device standards and regulations Extensive knowledge of GMP principles and their application in medical device manufacturing, including country‑specific regulatory requirements Knowledge of global regulatory requirements including risk management efforts and thorough risk assessments and mitigation strategies. Experience supporting customer/clinical studies, collecting data, and collaborating with customer/clinicians to ensure compliance with study protocols. Strong familiarity with rapid prototyping techniques. Experience with 3D solid modeling and technical drawings of medical devices desirable. Execution of Design for Manufacturability (DFM) principles and process characterization activities to design and develop products that are manufacturable and cost effective. Strong experience with Project Management (including organizing and facilitating meetings, project planning, balancing multiple projects, and budgeting) and Project management tools (e.g. MS Project). Knowledge of biocompatibility requirements and expertise in selecting appropriate materials for medical device applications and incorporating human factors engineering principles to optimize medical device usability and user experience. Knowledge of IP laws and practices, including patent applications and protection of proprietary technologies. Proven ability to lead cross‑functional teams to achieve project objectives. Leadership skills in establishing and managing comprehensive design control processes, ensuring adherence throughout the product lifecycle. Ability to work independently and also lead small teams in a fast‑paced, results‑oriented environment. Ability to generate complex prototypes using various materials and techniques to test and validate product designs. Ability to effectively communicate complex technical issues and solutions to non‑technical internal and/or external customers in both oral and written methods. Ability to create and maintain technical documentation, such as design specifications and test reports. 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