Job Description

Program Manager – Medical Devices

Location: Marlborough, MA (Hybrid, 3 days onsite)

Salary: $130,000–$170,000 base + 20% bonus + equity targets

Employment Type: Full-time, Permanent

Overview

We are seeking an accomplished Program Manager to lead complex, large-scale medical device development programs from concept through commercialization. This individual will manage multi-disciplinary teams and external development partners to deliver innovative, compliant, and high-quality medical products that improve patient outcomes.

This role is ideal for a technically strong, detail-driven program leader with a proven record of guiding advanced engineering projects, especially in Class II or Class III medical devices, through regulated design control environments.

Key Responsibilities

• Lead and manage all aspects of multi-phase, high-complexity medical device development programs.
• Provide technical leadership in the design, testing, and system integration of medical instruments and devices.
• Develop comprehensive project plans, schedules, and resource strategies; secure stakeholder alignment and approvals.
• Identify and assess project risks, escalate issues appropriately, and proactively drive resolution.
• Collaborate with engineering, quality, and manufacturing teams to ensure design control and regulatory compliance throughout all phases.
• Manage budgets and forecasts; track and report progress to senior leadership.
• Ensure timely delivery of project milestones within budget while maintaining top-tier quality.
• Foster cross-functional accountability, drive decision-making, and support performance development for project team members.
• Maintain robust communication with executive leadership, providing updates on variances, risks, and corrective actions.

Required Qualifications

• Bachelor’s degree in Engineering (Master’s preferred).
• 10+ years of technology development experience , ideally in laser systems, electro-opto-mechanical systems, or optics-based medical devices.
• 8+ years of project or program management experience in a regulated medical device environment (Class II or Class III).
• Demonstrated success delivering complex, multi-functional engineering projects on time and within budget.
• Proven ability to manage projects through a controlled product development process and design control lifecycle.
• Strong communication, leadership, and cross-functional coordination skills.
• Proficiency with project management methodologies, reporting, and stakeholder presentation tools.

Preferred Qualifications

• Experience with laser-based medical systems or laser device technology.
• In-depth knowledge of FDA QSRs , ISO 13485 , EU MDR , ISO 14971 , IEC 60601 , IEC 60825 , and IEC 62366 .
• Experience managing projects through full product development and rollout —ideally demonstrating long-term tenure (6+ years) within a single organization leading similar programs.

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