Sr. R&D Engineer – Advanced Development
| Company | Calyxo |
|---|---|
| Location | Pleasanton, CA, USA |
| Salary | $135000 – $165000 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field and a minimum of 5 years of medical device experience, OR
- Master’s degree in a related field and a minimum of 4 years of medical device experience, OR
- PhD in a related field and a minimum of 3 years of medical device experience.
- 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.
Responsibilities
- Lead the mechanical design, development, and testing of critical subsystems for an innovative kidney stone treatment device.
- Drive the product design efforts from concept to commercialization, 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 and validate test methods, create specifications, and execute design verification protocols, including writing reports and documentation.
- Ensure compliance with FDA regulatory standards, maintaining adherence to the design control process throughout the product development lifecycle.
- Manage external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.
- 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.
- Support manufacturing by collaborating with suppliers and internal teams to ensure product quality and seamless production.
Preferred Qualifications
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No preferred qualifications provided.