Manager - Biomedical Engineering (Ph.D.)Exponent • New York, NY, US
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Manager - Biomedical Engineering (Ph.D.)
Exponent • New York, NY, US
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job_description.job_card.job_description. in Bioengineering, Biomedical Engineering, Materials Science, or a related field At least 5 years . 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
Our Opportunity
We are currently seeking a Manager in ourPractice 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
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