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Exponent

Multidisciplinary science and engineering consulting

Manager – Biomedical Engineering - Ph.D

Regulatory & Quality (Life Sciences)Posted on Nov 5
Full-timeNew York, NY, USA$162k - $195k /yrIn-person

About the Job

Requirements

  • Manage and execute complex projects in support of clients.
  • Actively participate in and provide leadership in the Biomedical Engineering and Sciences Practice.
  • Actively market the Practice’s technical and regulatory capabilities to clients and the scientific community.
  • Participate in complex technical projects involving medical devices, pharmaceuticals, biologics, and combination products 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 regulatory objectives.
  • Develop additional expertise, gain industry exposure, and establish a new and expanded client base through technical consulting services.
  • Expand expertise through peer-reviewed publications and develop the careers of support staff.
  • Hold a Ph.D. in Bioengineering, Biomedical Engineering, Materials Science, or a related field.
  • Have at least 5 years of post-Ph.D. related professional experience, including experience with software as a medical device in the life sciences industry.
  • Have experience with medical device regulatory requirements, including United States Food and Drug Administration and European Union Medical Device Regulation requirements.
  • Have direct experience with total product lifecycle regulatory subject matter, including United States Food and Drug Administration Class II 510(k) and Class III Premarket Approval medical device regulation.
  • Have familiarity with quality assurance and risk management activities supporting medical devices and combination products related to software as a medical device.
  • Communicate highly technical issues effectively to non-technical audiences and collaborate with technical clients and regulatory bodies.
  • Demonstrate capabilities and skills that complement the existing consultants’ skills.
  • Be a recognized expert in the field with a strong publication history.
  • Have strong leadership skills and contribute as a strong technical and project contributor.
  • Attract projects and continuously expand business volume to support full-time staff, with the skills needed to manage, develop, and promote a group of professionals.
  • Have established client relationships or strong potential for business development through institutional support and resources.
  • Be legally authorized to work in the United States without immigration sponsorship or visa processing.

Responsibilities

  • Manage and execute complex client projects.
  • Provide leadership within the Biomedical Engineering and Sciences Practice.
  • Market the Practice’s technical and regulatory capabilities to clients and the scientific community.
  • Participate in complex technical projects involving medical devices, pharmaceuticals, biologics, and combination products.
  • Direct and perform regulatory strategy assessments, technical evaluations, analysis, and testing for multinational medical device companies.
  • Develop additional expertise and industry exposure while establishing an expanded client base through technical consulting services.
  • Publish in peer-reviewed venues and develop the careers of support staff.
  • Manage, develop, and promote a group of highly motivated professionals.

Desired Qualifications

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

About the Company

Exponent

Multidisciplinary science and engineering consulting

Exponent is a consulting firm that applies scientific and engineering expertise to help businesses, communities, and individuals solve complex problems and navigate change. Its team of over 950 consultants works across many industries and regions, offering multidisciplinary analysis and testing methods to develop actionable solutions. Revenue comes from fees for consulting services, tied to the ability to attract and retain clients and deliver effective results. Exponent differentiates itself through broad, cross-disciplinary capabilities, state-of-the-art testing, and a focus on technically solid, practically applicable outcomes. The company’s goal is to help clients address difficult challenges with rigorous, evidence-based guidance and to support them as they adapt to changing circumstances.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Fishers, IN
Founded
1967

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