A Day In The Life Of Our Senior Product Engineer, Accessories
- Create engineering drawings to effectively communicate design intent to suppliers.
- Work with technicians to assemble newly designed components into full device prototypes.
- Work with component suppliers to source both off-the-shelf and custom-designed parts. This will involve collaboration with suppliers from overseas.
- Work with suppliers to resolve issues such as component non-conformances, inspection methods, and documentation.
- Contribute to design verification and validation activities such as specification generation, test method development, test execution, and test protocol/report writing.
- Perform complaint investigations to understand root causes, and identify and implement opportunities for improving the robustness of components and assemblies
- Collaborate with manufacturing and quality teams to troubleshoot issues that arise during ongoing operations. This can include manufacturing/assembly processes and inspection processes.
- Exercise DFM (design for manufacturability) principles to enable cost-effective manufacture of the components and simplify assembly of the device.
- Develop and validate tools for site audit to ensure successful launch
- Work collaboratively and efficiently in a fast paced start-up environment with minimal supervision and guidance.
About You
- B.S. or M.S. in mechanical engineering or related engineering discipline.
- At least 5 years experience in the medical device industry.
- Proficient in using CAD for design of components and creating complex assemblies.
- Experience with relevant materials, precision machining processes and GD&T.
- Knowledge of various fabrication methods used in single use, complex medical devices(e.g. machining, plastic injection molding, MIM, laser cutting, stamping, rapid prototyping).
- Proven experience with verification, able to design and validate the fixture.
- Familiarity with defect reporting and root cause analysis.
- Understanding of risk management systems and how they impact product development processes.
- Demonstrated ability to work successfully in a team environment.
- Demonstrated basic project management skills.
- Self-motivated and proactive, with a passion for quality and continuous improvement.
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