Biomedical Engineering Manager
4 weeks ago
About the Role
We are seeking a highly skilled Manager to join our Biomedical Engineering & Sciences practice in Philadelphia, PA. As a Manager, 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, and actively marketing the Practice's technical and regulatory capabilities to clients and the scientific community.
Key Responsibilities
- Manage and execute complex projects in support of our clients
- Participate and provide leadership in our Biomedical Engineering & Sciences Practice
- Market the Practice's technical and regulatory capabilities to clients and the scientific community
- Participate in complex technical projects in medical devices, pharma, biologics, and combination products in support of our clients as part of multidisciplinary teams
- Direct and perform regulatory strategy assessments, technical evaluations, analysis, and testing on behalf of multinational medical device companies to support successful regulatory objectives
- Develop additional expertise, gain additional industry exposure, and establish a new and expanded client base through our unique technical consulting services
- Expand your own expertise through peer-reviewed publications and develop the careers of support staff
Requirements
- Ph.D. in Bioengineering, Biomedical Engineering, Materials Science, or a related field
- At least 5 years of related professional experience, including experience with quality systems 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 including international standards
- 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
- 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
What We Offer
At Exponent, we offer a dynamic and collaborative work environment, competitive benefits, and opportunities for professional growth and development. If you are a highly skilled and motivated individual with a passion for biomedical engineering and sciences, we encourage you to apply for this exciting opportunity.
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