Product Development Engineer
Boston/Westborough
DESCRIPTION:
The Product Development Engineer is part of a cross-functional engineering team driving the design, development, verification, and manufacturing transfer of novel interventional medical devices. The individual reports to the Director of Product Development.
RESPONSIBILITIES:
- Summary and refinement of product specifications
- Brainstorming of innovative device design concepts
- CAD design of device concepts
- Prototyping and evaluation of design concepts
- Engineering design analysis, including tolerance analysis
- Development and maintenance of drawing packages
- In-vitro test method development and fixture design/fabrication
- In-vivo and in-vitro study protocol development, execution, reporting
- Development of manufacturing processes and documentation
- Creation and maintenance of design controls documentation
- Generation of product risk analyses
- Initiation of document change orders, purchase orders or other business processes in support of product development activities
- Fostering of client relationships and provision of responsive service in a contract environment
- Adherence to Quality Management System procedures/design controls
PREFERRED QUALIFICATIONS
Preferred Education: B.S. in Mechanical or Biomedical Engineering
Preferred Experience:
- 0 to 4 years’ experience in product development in an engineering or manufacturing role
- Proficiency with MS Office suite and SolidWorks
- Familiarity with ISO 13485 and 21 CFR is preferred
- Familiarity with design for manufacturability is preferred
- Detail-oriented and comfortable working in a highly regulated environment
- Excellent analytical skills and the ability to solve complex design issues
- Strong communication and teamwork skills