Program Manager, Medical Device

Company Overview: Our client is a leading innovator in medical device technology, specializing in advanced laser-powered solutions that enhance patient care. Committed to cutting-edge innovation and excellence, they push the boundaries of medical advancements to improve healthcare outcomes. Join a company where innovation meets purpose and help shape the future of medical technology.

Job Description: The Program Manager for Medical Devices will play a critical role in planning and directly managing cross-functional projects that may include external resources and contracted companies. This position will partner with the development teams to drive accountability and high-quality project tasks and deliverables.

Responsibilities:

• Plans and directly manage cross-functional projects that may include external resources and contracted companies.
• Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.
• Proactively identify and assess areas of risk, escalate issues promptly, 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 projections.
• Monitors progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
• Provides management with regular project status, plan variances, and corrective action identification.
• 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.

Ideal Candidate:

• MS degree in an Engineering discipline or higher.
• Advanced skills in project management, project reporting, and presentations.
• 8 years of project management experience in one of the following areas: Class II electro-mechanical medical devices, electro-opto-mechanical systems, optics-based medical devices (Laser-based systems, Preferred)
• 10 years of 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.
• Ability to manage multiple projects in a fast-paced development environment.
• Proven experience working within a 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.