Senior Clinical Engineer

Laza Medical; Los Gatos (CA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Equity

Benefits package

Job summary

Laza Medical, a Shifamed Portfolio Company, seeks a Sr. Clinical Engineer to bridge engineering and clinical needs. This on-site role is based in Campbell, CA, reporting to our offices. You will translate user requirements into robust medical device designs for cardiovascular imaging robotics and AI-enabled solutions.

Ideal candidates have a biomedical/mechanical background with 5–7 years of hospital experience, and experience in design controls, usability, and regulatory collaboration.

Qualifications

• Bachelor's degree in biomedical/related engineering field.
• 5-7 years of experience in a similar role.
• Medical robotics and medical imaging experience is desirable.

Responsibilities

• Define and validate clinical and user requirements based on interviews and standards.
• Collaborate with engineering to address questions and refine requirements; contribute to design and testing.
• Design and implement experimental lab protocols for new feature development.
• Contribute to human factors and usability engineering activities.
• Analyze literature, registries, and tests to inform product development.
• Visit hospitals to observe procedures and clinical workflows.
• Collaborate with KOLs to gather expert feedback.
• Partner with regulatory to define preclinical/clinical testing strategies.
• Document requirements, protocols, and reports in design history file.

Skills

Hospital environment experience

Clinical collaboration

Engineering background

Design controls

Data analysis

Strong communication

Cross-functional teamwork

Statistical methods

Education

Bachelor's in Biomedical Engineering

Related engineering field

Tools

Statistical analysis software

Job description

Laza Medical, a Shifamed Portfolio Company, is at the forefront of developing state-of-the-art imaging solutions for cardiovascular applications. Our mission is to democratize top-quality cardiovascular imaging using robotics and AI. To learn more about Laza Medical, please visit https://lazamedical.com/.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

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.

NOTICE TO CANDIDATES:

Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].