Senior R&D Engineer, Advanced Development - Pleasanton, CA Pleasanton, CA

Senior R&D Engineer, Advanced Development - Pleasanton, CA

Pleasanton, CA

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary:

The Advanced Development team is responsible for early stage development and risk retirement of high risk and high reward design concepts. This team will develop proven ideas that work into the product development pipeline.

In This Role, You Will:

• Invent and evaluate early stage concepts. You will be asked to push limits and come up with creative and ground breaking solutions
• Lead the design, development, and testing of critical electromechanical and fluidics systems and subsystems for an innovative kidney stone treatment device.
• Drive early phase product design concept ensuring manufacturability, reliability, scalability, and cost-effectiveness.
• Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical, and Marketing) to create solutions that best meet user needs.
• Develop test methods, create specifications, and execute early phase feasibility testing, including writing reports and documentation.
• Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle.
• Use Solid Works to perform engineering calculations, create detailed models, and optimize product designs for manufacturing.
• Communicate project status, risks, and milestones effectively across all relevant departments.
• Collaborate with suppliers and internal teams to ensure product quality and seamless production.

Who You Will Report To:

• Vice President, Advanced Development

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 6 years of medical device experience, OR
• Master’s degree in a related field and a minimum of 5 years of medical device experience, OR
• PhD in a related field and a minimum of 3 years of medical device experience.
• Experience with early concept and design development of innovative medical devices, including brainstorming, feasibility assessments, and prototyping.
• Understanding of medical device regulations, including ISO 13485, FDA 21 CFR Part 820 (for design controls and quality management), as well as best practices for mechanical design validation and risk management.
• Proficiency in Solid Works and a strong understanding of design for manufacturability, tolerance analysis, and cost optimization.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.
• Strong problem‑solving and analytical skills, with a hands‑on approach to product development and testing.
• Demonstrated ability to innovate and create solutions with incomplete or ambiguous requirements.
• Work location:
  
  Pleasanton, CA
• Travel: less than 10%
• Full time employment
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

• A 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 vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.

All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.