Manager - Biomedical Engineering; Ph.D

Position: Manager - Biomedical Engineering (Ph.D.)
Location: New York

About Exponent

Exponentis the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients’ most profoundly unique, unprecedented, and urgent challenges. We are committed to engaging multidisciplinary teams of science, engineering, and regulatory experts to empower our clients with solutions that create a safer, healthier, more sustainable world. For over five decades, we've connected the lessons of past failures with tomorrow's solutions to advise clients as they innovate technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability.

Join our team of experts with degrees from top programs at over 500 universities and extensive experience spanning a variety of industries. At Exponent, you’ll contribute to the diverse pool of ideas, talents, backgrounds, and experiences that drives our collaborative teamwork and breakthrough insights. Plus, we help you grow your career through mentoring, sponsorship, and a culture of learning. Thanks for your interest in joining our team!

Key statistics:950+ Consultants
640+ Ph.D.s90+ Disciplines
30+ Offices globally

Our Opportunity

We are currently seeking a Manager in our Biomedical Engineering & Sciences Practice in New York, NY. In this role you will work as part of a team in a stimulating and challenging work environment with significant opportunities for professional growth.

You will be responsible for

Managing and executing complex projects in support of our clients

Actively participating and providing leadership in our Biomedical Engineering & Sciences Practice Actively marketing the Practice’s technical and regulatory capabilities to clients and the scientific community

Participating in complex technical projects in medical devices, pharma, biologics, and combination products in support of our clients as part of multidisciplinary teams

Directing and performing regulatory strategy assessments, technical evaluations, analysis, and testing on the behalf of multinational medical device companies to support successful regulatory objectives

Developing additional expertise, gaining additional industry exposure, and establishing a new and expanded client base through our unique technical consulting services

Expanding your own expertise through peer-reviewed publications and developing the careers of support staff

You will have the following skills and qualifications

Ph.D. in Bioengineering, Biomedical Engineering, Materials Science, or a related field

At least 5 years post-Ph.D. of related professional experience, including experience with software as a medical device in the life sciences industry

Experience with medical device regulatory requirements (FDA and EU MDR)
Direct experience with total product lifecycle regulatory subject matter including US FDA class II (510(k)) and class III (PMA) medical device regulation

Familiarity with quality assurance and risk management activities to support medical devices/combination products related to software as a medical device

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 our technical clients and interact with regulatory bodies

Demonstrated capabilities and skillset to complement the skills of our existing consultantsA recognized expert in your field with a strong publication history

Strong leadership skills and the desire to be a strong technical and project contributor

The ability to attract projects and continuously expand your business volume to support full-time staff and the skills needed to manage, develop, and promote a group of highly…