Sr. Mechanical Engineer

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