Program Manager

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**