**LOOKING FOR CANDIDATES WITH PROFESSIONAL ENGINEERING EXPERIENCE. RESEARCH ASSISTANTS OR RECENT INTERNS WOULD NOT BE CONSIDERED**
Key Points:
- -Prior experience as a sustaining engineer (R&D) in a medically regulated industry (Class II or III highly preferred)
- -Design verification and validation experience in the medical device industry
- -Basic understanding of Solidworks CAD system
- -Exposure to failure mode analysis.
- -PPK, MLTL, or any base level knowledge of statistical tools or analysis (Minitab use).
- -Test method validation
- -Design verification (plans & protocols), reporting, and testing
- -Data failure analysis on the design verification testing
Key Responsibilities:
- Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
- Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
- Create/update portions of design control documents including requirement specs and risk documents
- Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
Level of Independence:
- -Works independently without close supervision
- -Compares and evaluates possible courses of action after considering various possibilities
- -Applies his or her knowledge in following procedures or in determining which procedures to follow or
- determining whether specified standards are met
- -Considers the cause and effect of activities exhaustive, and which allow room for creativity and judgment
- -Direction tends to be high level and focused on end results with means of accomplishment left to
- incumbent
Education & Experience Required
- -Bachelor's degree in engineering required. Master's degree preferred.
- -3 + years experience required.
