Project Manager, Research and Development
2 months ago
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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