Mechanical Test Engineer
San Mateo Metro Area, CA
- Design novel mechanical test fixtures for implantable and wearable medical devices and manage their lifecycle: design, fabrication, assembly, maintenance, test, documentation, and release in PLM/QMS.
- Plan design of experiments, author test protocols, and execute/coordinate testing and inspection efforts to characterize and verify design and manufacturing processes, with inputs from cross-functional development team.
- Accurately document and clearly communicate test results through formal reports in accordance with international medical device regulatory requirements.
- Drive failure analysis efforts and communicate findings to cross-functional development team.
Qualifications and Skills
- Proficiency in mechanical fixture design in Solidworks and/or NX Unigraphics.
- Experience with standard inspection and test systems such as Instron, imaging scopes, measuring machines, force gauges and data loggers.
- Good engineering problem solving and analytical skills with proven ability to arrive at effective conclusions or solutions despite minimal direction.
- Good understanding of engineering fundamentals and proven hands-on mechanical skills.
- Detail-oriented and organized with good communication and interpersonal skills.
- M.S. or PhD in Mechanical Engineering, Materials Science, and Biomedical Engineering, or B.S with a focus on experimental work.
- One or more years of experience in medical device product development.
- One or more years of experience in product testing, analysis methodologies, and test documentation.
- Proven ability to thrive in a fast-paced, collaborative environment.