Program Manager – Medical Device
Marlborough, MA. Hybrid model 3 days onsite
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.
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