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Product Development Engineer II - Medical Devices

Freudenberg Group
United States, California, Carpinteria
June 28, 2023
Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with our partners, customers and the world of science, we develop leading-edge technologies, and excellent products, solutions and services for 40 market segments. The Freudenberg Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros. At Freudenberg Medical, we make products that save and improve the lives of people every day, all around the world. We are a global provider for medical device design and manufacturing with more than 2,000 employees. Innovation is at the core of our company, and we are proud of our industry-leading quality, lean manufacturing, and focus on innovation in products and processing technologies. Freudenberg Medical is an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare. You support our team as Product Development Engineer II - Medical Devices Responsibilities Leads straightforward or low complexity product development projects for medical devices to achieve on-time, quality results. Provides technical input for projects at all stages of the product life cycle. Maintains design controls, risk management and project management documentation in accordance with established regulatory requirements and SOPs. Creates performance and functional requirement specifications to comply with regulatory requirements and best-practice standards. Interacts with patients or physicians and applies empathy to identify novel solutions to unmet clinical needs. Generates CAD models, based on theoretical concepts, and detailed 2D drawings in support of assigned technical activities. Selects materials for medical device component parts and assemblies. Conducts Design Verification activities. Identifies and/or manages suppliers in the context of product development activities. Builds and tests prototype devices. Designs test fixtures, sources test equipment and develops procedures for testing products, including acceptance and rejection criteria. Conducts design verification to ensure consistency of design outputs against design inputs. Supports sustaining and compliance activities. Qualifications 3 years of Medical Device design & development experience. Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline. Advanced degree preferred. 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 and ISO 10993. 3D solid modelling (e.g., SolidWorks or related software) Design for manufacturability desired. Hands-on experience with machining and 3D prototyping methods preferred. Good mechanical, analytical & problem-solving skills. Good communication & interpersonal skills