Program Manager, Medical Device

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Job ID: 7608
Job Title: Program Manager, Medical Device
Location: Greater Boston Area, MA

Company Overview: Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. Committed to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

Job Description: The Program Manager for Medical Devices will play a critical role in planning and directly managing cross-functional projects that may include external resources and contracted companies. This position will partner with the development teams to drive accountability and high-quality project tasks and deliverables.

Responsibilities:

  • Plans and directly manage cross-functional projects that may include external resources and contracted companies.
  • Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
  • Proactively identify and assess areas of risk, escalate issues promptly, and proactively propose solutions.
  • Partners with development team members to drive accountability and high quality of project tasks and deliverables.
  • Continuous prioritization of team member activities and follow-up on actions.
  • Manages program budgets, generates forecasts, and tracks actuals against projections.
  • Monitors progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
  • Provides management with regular project status, plan variances, and corrective action identification.
  • Works closely with functional management to gain resource commitments and resolve issues.
  • Provides input to directors/managers and senior management on team member performance.
  • Effectively manages performance issues and conflicts.
  • Oversees and facilitates compliance to design control and product development processes.
  • Ensures project team activities and decisions are clearly communicated and documented.

Ideal Candidate:

  • MS degree in an Engineering discipline or higher.
  • Advanced skills in project management, project reporting, and presentations.
  • 8+ years of project management experience in one of the following areas Class II electro-mechanical medical devices (or) electro-opto-mechanical systems (or) optics-based medical devices (Laser-based systems, Preferred)
  • 10+ years of technology development experience in one of the following areas: laser systems, electro-opto-mechanical systems, optics-based medical devices.
  • Track record of executing complex multi-functional projects on time and within budget.
  • Ability to manage multiple projects in a fast-paced development environment.
  • Proven experience working within a controlled product development process.
  • Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR’s, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.