Sr. 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 designing and developing new solutions for critical components and accessories, integrating these solutions with the vision, sensors, and software R&D teams, and advancing an innovative, single-use kidney stone treatment device.

Responsibilities

• 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 injection molding and one or more of the following key areas: electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• 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.

Who You Will Report To

You will report to the Director, Instruments Engineering.

Work Location

Pleasanton, CA

Travel

Less than 10%

Full Time Employment

Compliance with Relevant County, State, and Federal Rules Regarding Vaccinations

What We Offer

• Competitive base salary range of $140,000 - $160,000 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 time off

Calyxo is Deeply Committed to Fostering an Environment Where Diversity and Inclusion Are Valued

Equal Opportunity Employer

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.