Clinical Engineer

We are representing an innovative Med Tech firm in the Bay Area who are seeking a Clinical Engineer to support the development, validation, and clinical deployment of innovative medical devices. This role sits at the intersection of engineering, clinical operations, and regulatory affairs, working closely with R&D, Quality, Regulatory, and external clinical partners to ensure devices are safe, effective, and fit for real-world clinical use.

• Serve as the technical and clinical liaison between engineering teams and clinical stakeholders (clinicians, trial sites, hospitals).
• Support clinical evaluations, feasibility studies, and clinical trials, including device setup, troubleshooting, and training.
• Translate clinical requirements and user feedback into clear engineering and product inputs.
• Support verification and validation (V&V) activities, usability testing, and human factors studies.
• Assist with risk management activities (FMEA, hazard analysis) and ensure alignment with IEC, ISO, and FDA requirements.
• Contribute to regulatory submissions by supporting clinical engineering documentation and technical sections.
• Provide on-site or remote clinical support during trials, pilots, or early commercial deployments.
• Collaborate with Quality and Manufacturing to support design changes, CAPAs, and post-market activities.
• Support customer feedback, complaint investigations, and continuous improvement initiatives.

• Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field.
• 2–6+ years of experience in clinical engineering, medical device development, or clinical support roles.
• Experience supporting clinical trials, usability studies, or hospital-based device deployment preferred.
• Familiarity with medical device regulations and standards (FDA QSR, ISO 13485, IEC 60601, IEC 62366).
• Strong communication skills with the ability to work effectively with both technical and clinical teams.
• Comfortable working in fast-paced, cross-functional environments.

• Experience with Class II or III medical devices
• Exposure to human factors engineering and usability testing
• Experience supporting regulatory submissions (510(k), PMA, CE Mark)
• Hands‑on experience in clinical or hospital environments

• Competitive salary and equity
• Opportunity to work on impactful medical technologies that improve patient care