Project Manager, Research and Development

5 days ago

Eden Prairie, United States Collagen Solutions Full time

Collagen Solutions is a global leader in tissue-based biomaterials and medical devices for use in regenerative medicine. We are an exciting fast-paced growth company looking for high caliber team members passionate about our vision:


To be the most trusted choice for medical biomaterial solutions


POSITION PURPOSE


The Project Manager, Research and Development works within R&D function to support & execute internal & contract product development & research projects. This position is a key role within the R&D organization ensuring innovative and quality products are delivered in a timely manner while maintaining compliance with industry standards and regulations.



ESSENTIAL FUNCTIONS AND RESPONSIBILITIES


  • Champion new product development projects: developing and securing regulatory approval for new regenerative medicine products.
  • Actively engage and collaborate on global cross functional product development teams.
  • Project management

-Scopes and prepares project plans and budgets.

-Actively manages project timelines and budgets, ensuring projects are delivered on time

and within budget

-Actively manages and mitigates project risks.

  • Partner closely with commercial team to assess and to develop client proposals and quotations.
  • Medical Device Design Control and Risk Management.
  • Prepare documentation in accordance with relevant internal SOPs.
  • Author engineering reports and presentations as required to document and communicate results.
  • Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
  • Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives.
  • Maintain a safe work environment.
  • Other duties as reasonably assigned by the management team.


QUALIFICATIONS


  • Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline.
  • 3+ years of medical device and design control experience.
  • Minimum 3 years of project management experience, PMP certification is a plus.


KNOWLEDGE & SKILLS


  • Thorough understanding of the medical device industry. Working knowledge of other related disciplines.
  • Experience in tissue engineering and biomaterials is a plus.
  • Ability to travel as needed (

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