Senior Clinical Engineer

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. 

We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience-designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

We are seeking a Senior Clinical Engineer  to join our growing Clinical team. This role will work closely with product development, engineering, and design & UX teams to support the planning, execution, and analysis of human and preclinical studies in a cross-functional and highly collaborative environment.

The portfolio of studies will span multiple phases of product development, from early R&D prototyping through research supporting regulatory submissions, including GLP and validation studies. The Staff Clinical Engineer will help translate observations and study results into meaningful clinical and technical insights that inform engineering, design & UX, quality, and other cross-functional teams.

This interdisciplinary role provides an opportunity to apply clinical and engineering knowledge to help answer design questions and improve the safety, effectiveness, and usability of products that integrate mechanical design, hardware, software, algorithms, and user interfaces.

RESPONSIBILITIES:

• Collaborate with cross-functional teams including engineering, design & UX, quality, manufacturing, regulatory, marketing, and clinical teams to support product development.
• Support the identification and documentation of clinical and user needs, product requirements, and potential product enhancements.
• Act as clinical SME to provide clinical and technical input to product design assessment including risk analysis, clinical performance evaluation, and usability assessments.
• Develop and execute test methods and study protocols to evaluate and validate products, testing models, and processes. Studies may include volunteer wear studies, GLP protocols, human factors validation, and clinical trials conducted internally or externally.
• Collect, analyze, and interpret study and test data; document results and contribute to technical reports and recommendations.
• Identify and troubleshoot clinical and technical issues in collaboration with engineering and other cross-functional partners.
• Communicate study observations and findings to cross-functional teams to support design decisions and product improvements.
• Develop and maintain study documentation, training materials, work instructions, and other clinical engineering documentation as needed.
• Support continuous improvement of clinical engineering processes, tools, and testing methodologies.

QUALIFICATIONS:

• Bachelor’s degree in engineering, biomedical engineering, life sciences, or a related scientific discipline.
• 5+ years of relevant industry experience in clinical engineering, biomedical engineering, human factors engineering, medical device or product development, or a related field.
• Medical device industry experience strongly preferred, particularly experience supporting product development, verification/validation, human factors, preclinical, or clinical activities.
• Experience developing and executing test protocols, analyzing data, and documenting technical results.
• Working knowledge of product development, design controls, risk management, and verification and validation principles within a regulated environment preferred. Experience with human factors/usability testing for medical devices strongly preferred.
• Strong analytical and problem-solving skills with the ability to apply sound technical judgment.
• Strong written and verbal communication skills with the ability to communicate technical and clinical information to cross-functional audiences.
• Ability to manage multiple priorities, maintain attention to detail, and work with increasing independence.
• Demonstrated ability to collaborate effectively in a multidisciplinary, fast-paced environment.
• Ability to travel as required to support studies and project activities.

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options
• 90% employer-paid medical, dental, and vision insurance
• Company-paid Basic Life Insurance
• 401(k) retirement plan (Traditional and Roth)
• Competitive Paid Time Off
• Paid Holidays
• FSA (Flexible Spending Accounts)
• HSA (Health Savings Account)
• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $130,000 - $150,00

Element Science is an Equal Opportunity Employer.  All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. 

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.  We are not able to sponsor individuals for employment visas for this job.  

At this time, we are unable to offer relocation assistance at Element Science.