Description:
We are seeking a dynamic and skilled Sr. Clinical Engineer to bridge the gap between our engineering teams and the clinical community. This role is vital in ensuring our products not only meet but exceed the expectations and needs of clinicians. The ideal candidate will possess a strong engineering background, with a preference for experience in biomedical, mechanical, or related disciplines. This is a full time on-site position and will require reporting to our offices located in Campbell, CA.
Responsibilities, Skills & Hands-On Experience:
- Define and validate clinical and user requirements based on user interviews, quality standards, risk analysis, and literature review.
- Collaborate with engineering teams to address open questions and refine user requirements; contribute to the product's architecture, design, and testing phases.
- Design and implement experimental lab protocols to support new feature development and de-risking activities.
- Contribute to human factors and usability engineering activities.
- Analyze data from literature, registries, and tests to inform product development and improvement.
- Visit hospitals to observe procedures, gaining firsthand insights into clinical workflows.
- Collaborate with Key Opinion Leaders (KOLs) to gather expert feedback and perspectives.
- Partner with regulatory team to define and execute preclinical and clinical testing strategies.
- Document requirements, protocols/test methods, and reports in design history file.
Preferred Skills & Hands-On Experience:
- Experience in hospital and clinical environments, directly observing and collaborating with healthcare professionals.
- Strong engineering and analytical background, with prior experience in design engineering, systems engineering, or human factors engineering.
- Experience in developing under medical device design controls and conducting design validation activities.
- Proficiency in basic statistics and data analysis.
- Ability to decompose complex problems into manageable components.
- Experience with early-stage medical technology with both hardware and software components.
- Quick learner with the ability to acquire new technical skills efficiently.
- Exceptional communication skills to mediate between clinicians and engineers.
Education & Work Experience:
- Bachelor's in Biomedical Engineering, Bioengineering, Mechanical Engineering, Electrical Engineering or related field.
- 5-7 years of experience in similar role.
- Medical robotics and medical imaging experience is desirable.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $125,000 to $150,000 + equity + benefits.
