Staff Clinical Engineer

SUMMARY OF ROLE:

We are seeking a Staff 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 Clinical Engineer II 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.
• 10+ 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: $155,000 - $170,000