Job Description
Job Description
PURPOSE OF JOB:
Use mechanical engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.
RESPONSIBILITIES:
- Apply mechanical engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost.
- Solve mechanical engineering problems at the component through system level.
- Conduct testing utilizing existing test protocols or develop new ones as needed
- Generate written reports
- Assign work to technicians and temporary workers as needed.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Contribute to the intellectual property position of the company via invention and patent applications
- Maintain accurate documentation of concepts, designs, drawings, and processes
- Maintain current knowledge of competitive technologies in addition to medical, technical and biomedical developments related to company products.
- Provide mechanical engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Oversee outside vendors and consultants as required
- Maintain QSR systems including pre-production quality assurance procedures, pre-clinical testing programs and post production QSR compliance in coordination with the Document Control, Clinical and Quality Assurance functions.
- Provide mechanical engineering support in the resolution of product complaints and/or safety issues.
- Work with other engineering, manufacturing, clinical affairs, sales and marketing and quality assurance staff to coordinate pilot production of new products.
- Support company goals and objectives, policies and procedures, QSR and FDA regulations.
PREFERRED EDUCATION/EXPERIENCE:
- BSME (or equivalent) and 0 to 5 years of experience or AA and 6 years of experience
ADDITIONAL SKILLS:
- Working knowledge of CAD. Ability to perform word processing and create basic spreadsheets