Sustaining R&D Engineer

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; give 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 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.