Staff R&D Engineer, Instruments - Pleasanton, CA

About the role

The Instruments Engineering team at Calyxo, Inc. is responsible for developing and driving the company's instruments and accessories through to launch. This role involves leading design and development activities for both released and next-generation devices and accessories, ensuring seamless integration with vision, sensors, and software.

Responsibilities

• Lead design and development activities of new single-use devices and accessories
• Act as a technical lead for these activities, and a core team lead when required
• 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
• 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
• 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
• 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 track record of taking new designs from concept stage through to commercialization
• Proven ability to apply Design for Manufacturability (DFM) principles to create scalable designs
• Proven design capabilities in two or more of the following key areas: injection molding, electromechanical sub-systems, catheter construction, endoscope construction, fluidics
• Proficiency in SolidWorks and a strong understanding of DFM, tolerance stack analysis, and GD&T
• Proficiency in conducting structured Design of Experiments (DOE) 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 creating and running simulations (CFD, FEA) to inform product development
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing

Who You Will Report To

You will report to the Director, Instruments Engineering.

Work location

Pleasanton, CA

Travel

Less than 10%

Full time employment

What We Offer

• A competitive base salary range of $175,000 - $190,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance, and paid vacation

Legal authorization to work in the United States is required

Disclaimer

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.