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Program Manager

Program Manager

Softworld, a Kelly CompanyMillbury, MA, United States
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Job Title : Program Manager

Job Location : Marlborough MA 01540 (Hybrid)

Onsite Requirements :

  • Prior Med Device experience (Class 2 or Class 3) a must.
  • 10+ years technology development experience in one of the following areas :

laser systems, electro-opto-mechanical systems, optics-based medical devices

  • 8+ years project management experience (complex laser-based systems preferred)

    • Job Description :

  • We are looking for someone to be responsible for managing large-scale, highly complex, multi-faceted new medical product development programs, involving internal and external development partners.
  • Provides technical leadership in design, test and system integration of medical devices and instruments.
  • Plans of all program subsystem and project deliverables.
  • Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
  • Proactively identify and assess areas of risk, escalate issues in a timely manner 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 forecasts.
  • Monitors progress to plan and implements corrective actions or contingencies as needed to maintain commitments.
  • Provides management with regular project status, variances to plan, and identification of corrective actions.
  • 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.

    • Requirements :

  • Prior Med Device experience (Class 2 or Class 3) a must.
  • Laser system / device experience a plus.
  • BS degree (MS preferred) in an Engineering discipline.
  • Advanced skills in project management, projects reporting and presentations.
  • 8+ years project management experience (complex laser-based systems preferred)
  • 10+ years 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.
  • Proven experience working within 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.
  • 3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.
  • This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future
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    Program Manager • Millbury, MA, United States