Biomedical Associate: Lab Testing & Regulatory Insight

Exponent Inc.; Philadelphia (Philadelphia County); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Exponent Inc. in Philadelphia, PA seeks a Biomedical Associate to join the Biomedical Engineering and Sciences Practice. You will work on cardiovascular and pulmonary test systems, support regulatory submissions, and assist in litigation support for medical devices and life sciences projects.

The role requires a Ph.D. in Mechanical or Biomedical Engineering or related field, with cell biology experience and hands-on lab test development.

Qualifikationen

• 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.
• Experience developing and validating test systems or experimental rigs for evaluating product or physiological performance.
• 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.

Aufgaben

• Design, develop, and execute laboratory test systems and protocols to evaluate medical devices and physiological performance.
• Provide technical evaluations, scientific analysis, and testing for FDA regulatory submissions and compliance.
• Support product liability litigation and IP matters through technical analysis and expert reports.
• Synthesize scientific and engineering information to communicate conclusions to engineering, business, legal, and industry audiences.
• Write technical reports for regulators, clients, and litigation matters.

Kenntnisse

Laboratory test systems

Cardiopulmonary physiology

Technical reporting

Teamwork and leadership

Communication skills

Ausbildung

Ph.D. in Mechanical/Biomedical Engineering or related field

Jobbeschreibung

Exponent Inc. in Philadelphia, PA seeks a Biomedical Associate to join the Biomedical Engineering and Sciences Practice. You will work on cardiovascular and pulmonary test systems, support regulatory submissions, and assist in litigation support for medical devices and life sciences projects.

The role requires a Ph.D. in Mechanical or Biomedical Engineering or related field, with cell biology experience and hands-on lab test development.