Clinical Engineering Specialist
Location: Petaluma, CA (Onsite)
Employment Type: Contract or Contract-to-Hire
Pay Range: $80-$90/hr. depending on relevant experience

About the Company
Our client is a rapidly growing medical device and pharmaceutical organization dedicated to bringing innovative antimicrobial solutions to market. The company combines device and drug expertise, operates under strict FDA regulations, and is scaling up for upcoming product launches. Team members thrive in a startup-style environment that values initiative, accountability, and technical collaboration.
About the Role
The Clinical Engineering Specialist will work at the intersection of engineering and clinical research to ensure medical devices perform safely and effectively in real-world use. This role partners with physicians, hospitals, and internal engineering teams to design and execute clinical evaluations. Results will feed directly into design verification, product optimization, and regulatory submissions.
Key Responsibilities

• Collaborate with engineering teams to design and execute clinical studies that validate device performance.
  

• Manage Class II and Class III device evaluations, including PMA, 510(k), and post-market surveillance studies.
  

• Partner with investigators, hospitals, and clinical sites to carry out study protocols.
  

• Collect and analyze engineering-relevant performance data from trials and provide feedback to product teams.
  

• Ensure trial data aligns with FDA requirements and supports regulatory filings.

Qualifications

• Bachelor’s degree in Engineering or related field (advanced degree preferred).
  

• 5+ years of experience in clinical research or clinical engineering within the medical device industry.
  

• Strong understanding of FDA clinical study requirements (PMA, 510(k), post-market).
  

• Proven ability to manage investigator relationships and site execution.
  

• Strong data analysis, communication, and technical collaboration skills.

9947415