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.
Preferred Qualifications and 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.