Principal Device Engineer

Sanofi-posted about 1 year ago
Full-time • Principal
Remote • Morristown, NJ
10,001+ employees
Chemical Manufacturing
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The Principal Device Engineer at Sanofi will lead the development of innovative medical device technologies, ensuring they are clinically ready and transitioning them to full commercial development. This role is pivotal in supporting the Global Medical Device and Packaging organization by delivering differentiated technology solutions that enhance drug and vaccine value, ultimately improving patient outcomes. The engineer will interface with cross-functional teams, manage device-related development activities, and ensure alignment with clinical program needs.

  • Lead and facilitate device development and technology innovation based on clinical and patient needs, commercial and operational requirements and industry trends.
  • Work with new device technology research team to evaluate new device technology and product solutions for early-stage program development.
  • Lead the development of prototypes and ensure rigorous testing to validate the performance and safety into the final combination products.
  • Conduct required studies and impact assessment by working with internal and external partners and stakeholders to establish technical and commercial feasibility.
  • Advance the novel technology and product concepts to be clinical ready and create full development roadmap.
  • Embedded into cross-functional program teams serving as the single point of contact of GDPU function for device programs.
  • Interface with internal and external device development partners to align resource and priorities to transition and support new device development programs.
  • Align with key stakeholders on the selected device solution to meet clinical program needs.
  • Generate the integrated development plan and resource need.
  • Manage all device related development activities to ensure on-time, on-budget execution.
  • Provide support and leadership in due diligence efforts involving novel device technologies.
  • Bachelor of Science in engineering or scientific discipline and 10+ years' experience in combination product or medical device development of complex technical products or Advanced degree in engineering or life sciences and 5+ years.
  • Expert in device design from innovation to late-stage development.
  • Experience with autoinjectors or insertion mechanisms.
  • Experience working with research and clinical development teams, solid understanding of related issues and challenges.
  • Experience in third party management (of manufacturers and vendors) is preferred.
  • Expertise around regulatory requirements for parenteral combination products is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366).
  • Strong knowledge of the US/EU external device-mediated drug delivery technology innovation eco-system.
  • Solid experience in technology development through external partnership with third parties.
  • Experience in third party management (of manufacturers and vendors) is preferred.
  • Expertise around regulatory requirements for parenteral combination products is preferred (21 CFR parts 4 & 820, ISO 13485, 14971 & IEC 62366).
  • High-quality healthcare coverage
  • Prevention and wellness programs
  • At least 14 weeks' gender-neutral parental leave
  • Opportunities for career growth and development
  • Supportive work environment that encourages innovation and collaboration.
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