Job Description

Senior R&D Engineer

Client:

Our client is an innovative startup company that is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

About the Senior 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 their instruments and accessories through to launch. In this role, you will drive the design and development of new solutions for both released and next-generation critical components and accessories, integrating these solutions alongside the vision, sensors, and software R&D teams, 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 bring these novel concepts through all phases of development to commercialization.

In this Role, You Will Also:

• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.
• Define 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.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Develop and validate verification test methods, create and execute protocols, and author associated reports and risk documentation.
• 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 5 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 4 years of medical device experience
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• 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.
• Track record of taking design concepts from prototyping stage through to design maturation.
• Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
• 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.
• Work location: Pleasanton, CA

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