R&D PROJECT MANAGER

Department: Research Development

We are looking for a R&D Project Manager to be responsible for all elements of new product development lifecycle and product improvement projects in the field of in-vitro diagnostics/clinical chemistry. As the R&D Project Manager, you must have a familiarity with Design Control, verification/validations, and risk assessments as per current FDA, ISO, and IVD Directive standards.

RESPONSIBILITIES:

  • Manage all aspects of R&D Projects from feasibility through post-launch activities.
  • Lead the Design Control process and coordinate strategic planning, design reviews, risk assessments, and other related cross-functional meetings.
  • Prepare, approve, and maintain design history file (DHF) documentation. Track timelines and budgets associated with all projects within the department.
  • Prepare and review proposals for prospective product development or improvement projects to ensure technical feasibility, accuracy, cost analysis, and market analysis.
  • Assist with product transfer and process/design validation activities. Supervises and mentors junior R&D staff.
  • Interface with Quality, Regulatory, Sales & Marketing and Manufacturing groups to ensure company project objectives are met.

QUALIFICATIONS:

  • Bachelor of Science degree in a relevant scientific discipline; Advanced scientific degrees are preferred.
  • At least 10 years of proven experience in an R&D and/or Project Management position.
  • Project management, lean manufacturing, six sigma or similar process improvement certification preferred.
  • Experience working under cGMP/FDA/ISO regulated environment.
  • Best practices in Project Management tracking, budgeting, and documentation. Intimate knowledge and application of Design Controls as per the FDA 21 CFR 820.
  • Good understanding of the In-vitro diagnostic/clinical chemistry industry, particularly in the development of quality control materials.

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