Manager - Biomedical Engineering (Ph.D.)

Exponent; New York (NY); On-site; USD 162,000 - 195,000; Full time

Job summary

Exponent in New York, NY is seeking a Manager in Biomedical Engineering & Sciences. You will lead complex projects, guide regulatory strategy, and help expand client relationships within a multidisciplinary team.

The role requires a Ph.D. and 5+ years post‑doctoral experience, deep knowledge of FDA and EU MDR, and proven leadership. This is a full-time, in-office position with opportunities for professional growth and industry impact.

Qualifications

• Ph.D. in Bioengineering, Biomedical Engineering, Materials Science, or related field.
• Minimum 5 years post-Ph.D. experience in life sciences/medical devices.
• Experience with FDA and EU MDR regulatory requirements.
• Lifecycle regulatory work including US 510(k) and PMA processes.
• Strong written and verbal communication for technical and regulatory audiences.

Responsibilities

• Manage and execute complex projects for clients in medical devices and life sciences.
• Provide leadership within the Biomedical Engineering & Sciences Practice.
• Market the Practice's capabilities to clients and the scientific community.
• Lead regulatory strategy, assessments, testing and documentation for regulatory approvals.
• Grow client base and expand staff development through consulting work.
• Publish and share expertise to advance the practice and team.

Skills

Regulatory leadership

Business development

Technical communication

Project management

Strategic thinking

Team leadership

Education

Ph.D. in Bioengineering / Biomedical Engineering / Materials Science

Job description

Manager - Biomedical Engineering (Ph.D.)

• Location: US-NY-New York


• Practice: Biomedical Engineering and Sciences


• Position Type: Full-time


• Posted Salary Range: USD $162,000.00 - USD $195,000.00 /Yr.

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.

Responsibilities

• Managing and executing complex projects in support of our clients


• Actively participating and providing leadership in the 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 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

Required Skills & 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 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

Exponent is a proud equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.