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Exponent · 1 day ago

Manager - Biomedical Engineering (Ph.D.)

New York, NY

Full-time

Onsite

Senior Level

$146K/yr - $198K/yr

5+ years exp

Exponent is a premium engineering and scientific consulting firm dedicated to solving unique challenges for clients. The Manager in the Biomedical Engineering & Sciences Practice will lead complex projects, provide technical and regulatory expertise, and contribute to business development in the medical device and life sciences sectors.

Consulting

No H1B

Responsibilities

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

Qualification

Ph.D. in Biomedical EngineeringMedical device regulatory experienceTotal product lifecycle regulationSoftware as a medical deviceQuality assuranceRisk managementClient relationship managementBusiness development potentialOutstanding communication skillsLeadership skills

Required

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 consultants

A 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 motivated professionals

Established client relationships and a thriving consulting business is highly desirable; individuals with strong potential for business development through institutional support and resources will also be considered

Presently legally authorized to work in the US, no immigration sponsorship or visa processing required