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

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 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.

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 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

Work location: Pleasanton, CA

Travel: less than 10%

Full time employment

Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced, and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer 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