Product Development Engineer II
Neptune Medical · Burlingame, CA · 4 mo ago
On-siteEngineering$100k–$130k/yrFull-time
Roles and Responsibilities
- Develop and execute test methods for a complex, robotically driven medical device.
- Design, prototype and build custom electromechanical fixturing.
- Develop software scripts to control robotic platforms and tools to perform data post-processing and analysis.
- Apply principles of systems engineering, design controls and risk management to the development of a medical device.
- Define and maintain design requirements based on stakeholder needs and product safety.
- Use statistical analysis techniques to support data-driven decision making and define acceptance criteria for design verification testing.
- Identify and root cause product issues or defects.
- Implement test process improvements to drive better accuracy, repeatability, and reproducibility of results.
- Author, release and maintain robust documentation in a product lifecycle management (PLM) system.
- Prepare and present technical read-outs to cross-functional audiences including engineers, quality and regulatory personnel, and leadership.
- Emphasize product quality, patient safety, data integrity and other principles of GxP.
Required Qualifications
- B.S. or M.S. in Mechanical, Biomedical or related field of Engineering.
- 3+ years of work experience.
- Demonstrated experience working with cross functional teams.
- Experience with test engineering and/or design verification.
- Solid understanding of design controls and risk management.
PREFERRED QUALIFICATIONS
- Experience working in the medical device industry and/or other regulated environments.
- Experience with disposables/consumables.
- Experience with electromechanical and/or robotic systems.
- Experience working in a start-up environment.
- Experience with PLM/ALM tools.
- Experience using statistical techniques to analyze quantitative data.
- Experience with rapid prototyping.
- Experience with test method validation, fixture qualification and/or non-product software validation.
- Proficient with Minitab.
- Proficient with Solidworks.
- Proficient with Linux-based operating systems.
- Proficient with Python.