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Program Director

4 weeks ago

Woodbridge, Canada Modern Technical Staffing Inc. Full time
Program Manager

Modern Technical Staffing Inc. is seeking a skilled Program Manager to lead the development of new medical devices. The ideal candidate will have a strong understanding of FDA, ICH, and IEC standards and experience with class 2 or 3 medical devices.

Key Responsibilities:
  • Lead the Extended Operations Team to ensure on-time and on-budget performance through the new product development cycle.
  • Create strategic solutions to meet anticipated customer and business needs with predictability and certainty.
  • Ensure scope, cost, resource, and schedule alignment between operations and core team functions.
  • Follow compliance processes for New Product Development.
  • Skilled negotiator with demonstrated ability to create mutually beneficial results and negotiate trade-offs.
  • Execute pre-established Operations Strategies.
  • Ensure structured problem methods and predictive engineering principles are consistently and rigorously applied, such as Design for Six Sigma, Lean Manufacturing, or similar concepts.
  • Strong organizational and analytical skills (able to review results/situations and determine follow-up action plans).
  • Ability to work to close deadlines.
  • Adaptable and flexible – able to take on additional work requirements, in addition to core responsibilities, as required.
  • Create reports for internal use and for client presentations.
Requirements:
  • Bachelor's or advanced degree in a technical field such as Industrial Engineering, Mechanical Engineering, Material Science, Chemical Engineering, Biomedical Engineering, Electrical.
  • Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years relevant experience with full product lifecycle with understanding of development lifecycle and various technology methodologies that support that lifecycle.
  • Medical device product development (Class 2 or 3) experience and a strong understanding of FDA, ICH, and IEC standards.
  • Proven Operations experience with depth of knowledge in at least two Operations functions and Program Management experience.
  • Experience with class 2 or 3 medical devices.
  • Experience with problem-solving methodologies.
  • Experience working in virtual teams.
  • Experience in new product development.
  • Experience across the entire product lifecycle.
  • PMP Certified.