Peterborough, United States
about 1 year ago
SR PRINCIPAL PRODUCT ENGINEER
- Conceptualization: design, prototype, and test concepts for medical devices, components, and other products on the product and technology roadmap. This includes interfacing with the marketing team to understand the customer needs and user requirements that are needed to develop product requirements.
- Development: move a product from concept to a production design.
- Testing: ensure the design meets functional and safety requirements, is compliant with regulatory standards and meets user needs.
- Design Transfer: transition designs into volume production, typically with a contract manufacturer.
- Sustaining: resolve issues for legacy products that are in active production.
- Design Controls: support the documentation requirements of the quality medical system process, inclusive of requirements, design descriptions, drawings, testing, design review, risk management and ECO.
Experience and Qualifications
- Minimum of a Bachelors degree in Engineering
- Minimum of ten years direct product development experience
- Experience with device development from concept to commercialization
- Well rounded generalist, with a grasp on all aspect of engineering and product design-preferred specialist in mechanical design
- Rapid prototyping capability is a must.
- Quality Systems: Understanding of the design control deliverables required of 21CFR Part 820 FDA Quality Systems Regulations and ISO 13485