Job ID: 7674
Job Title: Program Manager – Medical Device
Location: Greater Boston, MA
Our client is a leading innovator in medical device technology, specializing in cutting-edge, laser-powered solutions that advance patient care. Their mission is to push the boundaries of what’s possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.
If you’re passionate about making a real impact in the world of medical technology, this is your opportunity to join a purpose-driven team that’s shaping the future of healthcare—one innovation at a time.
Job Description: In this role, you will be responsible for managing large-scale, highly complex, multi-faceted new medical product development programs, involving internal and external development partners.
Responsibilities:
- Plans and directly manages 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 with design control and product development processes.
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.
