Staff R&D Engineer

Staff R&D Engineer, Instruments

Pleasanton, CA

Company:

Our client is growing startup company that is changing the future of Kidney Stone treatment with an innovative single use device. Their team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

About the Staff R&D Instruments Engineer Role

The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving instruments and accessories through to launch. In this role, you will lead the design and development of new solutions for released and next-generation devices and accessories, ensuring seamless integration of mechanical systems with vision, sensors, and software, and catalyzing the advancement of an innovative, single-use kidney stone treatment device. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to successfully drive these novel concepts through all phases of development to commercialization.

In This Role, You Will:

• Lead the design and development of new single-use devices and accessories, serving as a technical lead for the team, and a core team lead for R&D and cross-functional project teams.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.
• Define and lead qualification strategies for new designs or processes, working in partnership with other teams across the organization to gain alignment.
• Meaningfully translate customer requirements into new or revised product requirements and engineering specifications.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Generate purposeful Intellectual Property (IP) and contribute to the overall IP portfolio.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Develop test methods, create and execute protocols, and author associated reports and risk documentation.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 10 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 9 years of medical device experience.
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• Experience leading technical teams and providing mentorship to other engineers.
• Proven ability to apply DFX principles to create designs that can scale.
• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.
• Proven design capabilities in two or more of the following key areas: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Proficiency in conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
• Proven track record of taking new designs from concept stage through to commercialization.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.