Senior Program Manager, Medical Systems - Marlborough, MA

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Responsibilities:

• Plans and directly manages cross-functional projects that includes external resources and contracted companies.
• Formulates and gains approval for overall project plans in consultation with senior management, CDMOs, Regulatory, Quality, Manufacturing and other stakeholders.
• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively develop solutions including contingency plans to address program risks and resolution of technical knowledge gaps that gate program progress.
• 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.

Education requirements

• Degree in Engineering discipline, MS Preferred.
• Advanced skills in project management, projects reporting and presentations.
• Excellent written and verbal communication skills.

Experience requirements

• 5+ years project management experience of Single-Use Medical devices, preferred experience with endoscopes and peripheral equipment and accessories.
• Working knowledge of MS Project or an equivalent project planning SW.
• 15+ years medical device experience and at least 4 years in the following areas: Endoscopy, Digital image processing, Systems Engineering knowledge preferred.
• Experience with transfer to manufacturing of medical products including management of IQ, OQ, PQ, DMRI, Work Instructions, Product Specifications, PFMEAs, MVPs, and other transfer related documentation.
• Track record of executing complex multi-functional project on time and within budget.
• Ability to manage multiple project work streams in a fast-paced development environment.
• Proven experience working within controlled "Stage Gate" 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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