Product Development Engineer II

Position Summary

The Product Development Engineer II will focus on testing the performance of our product and using test results to drive product improvement. A successful candidate will possess a passion for medical device engineering and a record of developing test methods for hardware devices in engineering R&D environments. This role will engage in cross-functional collaboration to define requirements and test acceptance criteria, perform risk management, and design experiments to reliably measure the performance of our product.

The ideal candidate will act with passion and intensity in a medical device start-up that is fast paced and collaborative and will display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

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.
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic regulations including Cal FDB, OSHA and Cal-OSHA.

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.
• A driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.

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.
• Familiarity 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.

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Pay and benefits

Our job titles may span more than one career level. The starting base salary for this role is between $100,000 and $130,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.