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

Calyxo • Pleasanton, CA

5d • Onsite

About The Position

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. 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.

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
• Legal authorization to work in the United States is required.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Responsibilities

• 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 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 meets 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.

Benefits

• Competitive base salary range of $140,000 - $160,000
• Variable incentive plan
• Stock options
• 401(k)
• Healthcare insurance
• Paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior