Staff Mechanical Engineer

Now Hiring | Staff Mechanical Engineer | Medical Device | San Diego, CA

We are partnering with a venture-backed medical device start-up developing a Class II electromechanical medical device. Our client is looking for a hands-on, experienced Staff Mechanical Engineer to play a pivotal role in the design and development of their capital equipment and disposable products.

If you're passionate about building life-changing medical technology and thrive in a fast-paced, mission-driven environment - let's talk.

What You'll Do

As a Staff Mechanical Engineer, you'll own mechanical design and development from concept through production, working across a highly collaborative cross-functional team spanning electrical, software, clinical, and manufacturing.

• Lead mechanical design and development of electromechanical components and subsystems
  
  
• Translate user needs and system requirements into technical specifications
  
  
• Own full product lifecycle activities including prototyping, testing, and design validation
  
  
• Guide hardware design verification and validation activities, including IEC 60601-1 compliance
  
  
• Conduct risk assessments (DFMEA) and implement design mitigations for thermal, mechanical, and safety-related hazards
  
  
• Troubleshoot complex mechanical issues across prototype and production systems
  
  
• Generate detailed technical documentation and work instructions
  
  
• Collaborate with supply chain and procurement to select and qualify critical vendors and components
  
  
• Partner with internal and external manufacturing teams to ensure manufacturability and scalability
  
  
• Support audits, inspections, and quality control initiatives throughout the development process

What We're Looking For

• B.S. in Mechanical Engineering or a closely related field required; M.S. preferred
  
  
• 6+ years of hands-on mechanical engineering experience, with increasing levels of responsibility
  
  
• Experience in a highly regulated industry - preferably Class II medical devices
  
  
• Strong understanding of thermodynamics, heat transfer, and fluid dynamics as applied to precision thermal control systems
  
  
• Proven ability to select materials compatible with chemically aggressive fluids and repeated thermal cycling
  
  
• Strong proficiency in CAD, preferably SolidWorks, with a track record of production-ready designs
  
  
• Solid understanding of manufacturing processes, quality control, and medical device regulatory compliance
  
  
• Demonstrated ability to lead technical teams or mentor junior engineers
  
  
• Excellent cross-functional communication skills and ability to engage with executive leadership
  
  
• Ability to manage multiple projects simultaneously in a fast-paced start-up environment

Bonus Points For

• Knowledge of FDA regulations and ISO standards for medical devices
  
  
• Hands-on experience designing closed-loop fluid systems operating at sub-zero temperatures
  
  
• Experience in thermal insulation design, condensation management, and low-temperature environment controls
  
  
• Background in refrigeration systems, cryogenics, or laboratory chillers in biomedical or industrial applications
  
  
• Contributions to intellectual property - invention disclosures or patent filings