Medical Device - Program Manager - Sudbury, MA

The Program Manager will oversee and coordinate cross-functional projects, ensuring the successful delivery of cutting-edge medical devices through effective collaboration with internal teams and external partners. With a strong background in laser-based systems and a deep understanding of regulatory standards, the Program Manager will drive accountability, manage project finances, and proactively address risks, all while maintaining a focus on high-quality execution and continuous process improvement.

Client Details

My client specializes in developing cutting-edge medical devices using advanced laser technology to enhance patient care. They are committed to innovation, sustainability, and building a diverse, engaged workforce to drive future success.

Description

Responsibilities:

• Oversees and manages cross-functional projects, including coordination with external partners and contractors.
• Develops comprehensive project plans in collaboration with senior management and key stakeholders, securing approval as necessary.
• Proactively identifies and evaluates potential risks, ensuring timely issue escalation and proposing effective solutions.
• Collaborates with development teams to ensure accountability and high-quality execution of project tasks and deliverables, with ongoing prioritization and follow-up on team actions.
• Manages program finances, including forecasting and tracking budgetary performance against actuals.
• Tracks project progress and implements corrective measures or contingency plans to stay aligned with commitments.
• Regularly updates management on project status, highlighting variances from the plan and recommending corrective actions.
• Works with functional leadership to secure necessary resources and address project-related challenges.
• Provides performance feedback to directors, managers, and senior leadership, addressing performance issues and conflicts as they arise.
• Ensures adherence to design control standards and product development processes throughout the project lifecycle.
• Guarantees clear and thorough communication and documentation of team activities and decisions.

Profile

Ideal Candidate:

• Education:
• Master's degree in an Engineering field or equivalent higher qualification.
• Skills:
• Strong expertise in project management, reporting, and delivering presentations.
• Exceptional written and verbal communication abilities.
• Experience:
• Over 5 years of project management experience with complex laser-based systems.
• More than 10 years of experience in technology development, specifically in laser systems, electro-optomechanical systems, or optics-based medical devices.
• Proven track record in successfully delivering complex, multi-functional projects on schedule and within budget.
• Skilled at managing multiple projects simultaneously in a dynamic, fast-paced development environment.
• Extensive experience working within structured product development processes.
• Familiarity with Design Controls and Risk Management practices, as well as regulations and standards such as FDA QSRs, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366 is highly desirable.

Job Offer

What's To Offer:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.