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

About the role

The Advanced Development team at Calyxo, Inc. 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.

Responsibilities

• Invent and evaluate early stage concepts
• 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 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 SolidWorks 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

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 SolidWorks 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.

Qualifications

• Full-time employment
• Travel: less than 10%
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Benefits

• An attractive compensation package, which includes 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

Skills

• Medical device experience
• Early concept and design development
• Feasibility assessments and prototyping
• Medical device regulations
• ISO 13485, FDA 21 CFR Part 820
• Design for manufacturability, tolerance analysis, and cost optimization
• Collaboration and communication skills
• Product development within regulated industries
• Problem-solving and analytical skills
• Innovation and solution creation

Pay

• $140,000 - $160,000 base salary range
• Variable incentive plan

Schedule

• Full-time employment

Benefits

• 401(k)
• Healthcare insurance
• Paid vacation

Company Culture

We are a diverse and inclusive workplace where you can work in a fun, dynamic environment with experienced, proven leaders and have the opportunity to shape our company culture. We offer a welcoming and supportive environment where you can learn and grow while contributing to a mission-driven company.

Equal Opportunity Employer

Calyxo is committed to fostering an environment where diversity and inclusion are valued and prioritized. We seek to create a welcoming and diverse community that empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

Legal Authorization

All applicants must have legal authorization to work in the United States.