Senior Mechanical Engineer
Must have a broad range of engineering skills ranging from R&D concepts thru product development and sustaining engineering with a demonstrated history of developing products with mechanical, electrical and software components.
Responsibilities
- Conceptualization: design, prototype, and test concepts for medical devices, components, and other products and technology based on customer needs and user 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 medical quality system process, including requirements, design descriptions, drawings, testing, design review, risk management and ECO.
- Intellectual Property Generation: contribute to and review patents related to current and new products.
- Communication: provide timeline, budget inputs and status to engineering and project management.
Competencies
- Analytical and Product Skills: Good analytical and problem-solving skills, with a drive toward innovation. Working knowledge of tooling and manufacturing processes, with the ability to work in a fast-paced, multidisciplinary environment. Demonstrates familiarity with rapid prototyping processes and quick product iteration. Takes a hands-on, sleeves-up approach to engineering.
- Quality Systems: Understanding of the design control deliverables required of 21CFR Part 820 FDA Quality Systems Regulations and ISO 13485
Experience and Qualifications
- Minimum of a Bachelors degree in Engineering
- Minimum of 7 years direct product development experience
- Experience with device development from concept to commercialization
- Mechanical engineering background with experience in cross-disciplinary work with electronics and software.
- Consumer and medical product experience preferred
- Minimum of 2 years of experience with SolidWorks. Complex surface modeling is a plus.
- First-hand experience with machining and part fabrication preferred
- Strong computer skills
- Strong engineering, design, and analysis skills