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

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.

• 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.

• Vice President, Advanced Development

• 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.

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. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. 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.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.