Biomedical Associate (Ph.D.)
Exponent
About the Role
Exponent is seeking a Biomedical Associate for its Biomedical Engineering and Sciences Practice in Philadelphia, PA. This role involves working within a multidisciplinary team to solve complex client challenges in the medical device and life sciences industries, focusing on both regulatory consulting and litigation support.
Key Responsibilities
- Designing, developing, and executing laboratory test systems and experimental protocols to evaluate the performance and safety of medical devices, with emphasis on cardiovascular and pulmonary applications.
- Performing technical evaluations, scientific analysis, and testing for medical device companies in support of FDA regulatory submissions and compliance activities.
- Supporting product liability litigation and intellectual property matters through technical analysis, root cause investigation, and expert report preparation.
- Gathering and synthesizing scientific and engineering information to communicate technical conclusions to diverse audiences (engineering, business, law, industry).
- Writing technical reports for regulatory agencies, industry clients, and litigation matters.
- Publishing at conferences and in peer-reviewed literature.
- Assisting in marketing the group's technical capabilities to clients and the scientific community.
- Developing additional expertise and industry exposure through Exponent's technical consulting model.
Requirements & Tech Stack
- Ph.D. (or equivalent) in Mechanical Engineering, Biomedical Engineering, or a closely related field.
- Academic training in cell and molecular biology, with practical laboratory experience in cell-based or biological assays.
- Demonstrated experience developing and validating test systems or experimental rigs for evaluating product or physiological performance in a laboratory setting.
- Working knowledge of cardiopulmonary physiology and the mechanical and biological behavior of cardiovascular and respiratory systems.
- Familiarity with FDA regulatory frameworks for medical devices (e.g., 21 CFR, design controls, biocompatibility standards) is a plus.
- Experience applicable to medical device development, regulatory testing, or failure analysis is highly desirable.
- Excellent written and verbal communication skills.
- Superior problem-solving abilities and strong attention to detail.
- Strong educational and publication credentials.
- Strong teamwork and leadership skills.
Applicants are encouraged to submit a CV with publications, including those in review or pending.