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Project Manager

Job description

PROJECT MANAGER
We're seeking a Project Manager to join our team at a small, innovative Class III medical device company specializing in breakthrough MedTech products. The ideal candidate is a mid-level professional with a proven track record of managing projects through design verification (DV) and regulatory submissions, specifically with 510(k) and Pre-Market Approval (PMA) experience. This role will support all company programs, from early-stage development to post-market activities, and requires a candidate who is hands-on and adept at navigating the unique challenges of a dynamic startup environment.
Responsibilities
  • Manage the entire project lifecycle for Class III medical devices, from initial concept through to commercialization and post-market surveillance.
  • Lead cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing, to ensure projects are delivered on time, within scope, and on budget.
  • Develop and maintain detailed project plans, schedules, and budgets, while proactively identifying and mitigating potential risks.
  • Oversee the design verification and validation processes, ensuring all activities are meticulously documented and meet regulatory requirements.
  • Coordinate the creation and submission of regulatory filings, including 510(k) and PMA applications, in collaboration with the regulatory team.
  • Manage supplier relationships and external partners, ensuring they meet project requirements and quality standards.
  • Facilitate effective communication among all stakeholders, providing regular updates on project status and key milestones.
  • Support the development and maintenance of quality system procedures related to project management.
Qualifications
  • Bachelor's degree in engineering, life sciences, or a related field.
  • Minimum of 5 years of project management experience in the medical device industry.
  • Demonstrated experience managing projects through design verification (DV).
  • Proven experience with 510(k) and/or PMA submissions.
  • Experience with catheter-based products is highly preferred.
  • Strong understanding of FDA regulations and ISO 13485.
  • Experience with supplier relations and management.
  • Excellent leadership, communication, and organizational skills.
  • Project Management Professional (PMP) certification is a plus.