Regulatory Senior Managing/Principal Engineer

Exponent, Inc. Philadelphia, PA
Exponent is a leading engineering and scientific consulting firm. Our multidisciplinary team of scientists, engineers, physicians, and regulatory consultants brings together more than 90 different disciplines to solve complicated problems facing corporations, insurers, government entities, associations and individuals. Our more than 1000 staff members work in 26 offices across the United States and abroad. Exponent has approximately 800 consultants, including more than 500 that have earned a doctorate in their chosen field of specialization.

Exponent's Biomedical Engineering Practice is currently hiring for a Regulatory Senior Managing/Principal Engineer in our United States offices. This position offers a stimulating and challenging work environment and significant opportunities for professional growth.

Responsibilities for this position include:

* Manage and execute complex projects related to preclinical strategy and all phases of the FDA product review and approval process of medical devices in support of our clients

* Active participation and leadership in our Biomedical Engineering Practice

* Actively market the groups technical capabilities to clients and the scientific community

* Develop additional expertise, gain additional industry exposure, and establish new and expanded client base through our unique technical consulting services

* Attract and develop new projects and clients

Qualifications for this position include:

* M.D., J.D., or M.S./Ph.D. in Bioengineering, Mechanical Engineering, Materials Engineering, Polymer Science or a related engineering field

* Direct experience in a product development environment in medical devices is required, including working knowledge of medical device design control, Risk Management, MDR and FDA regulatory environments

* Demonstrated experience in working with FDA and successful completion of 510(k) submissions and pre-IDE, IDE, PMA original submissions and subsequent revisions/supplements for medical devices

* Minimum of ten years of professional experience, with a minimum of five years as a consultant

* Outstanding verbal and written communication skills in order to effectively communicate highly technical issues to a non-technical audience while possessing the technical depth to collaborate with physicians and interact with regulatory bodies

* Must be a recognized expert in his/her field with a strong publication history

* Established client relationships and a thriving consulting business is highly desirable

* Must be able to attract projects and continuously expand his/her business volume to support full-time staff and have the skills needed to manage, develop, and promote a group of highly motivated professionals

* Testifying experience in trials and/or before government panels is an asset

* The ideal candidate will be expected to continuously expand his/her own expertise through peer-reviewed publications

We are an Affirmative Action, Equal Employment Opportunity, Veterans and Disabled Employer.