Program Manager Product Development (Medical Devices)

Location: Onsite in Waltham, Massachusetts, United States

Salary: $190,000–$270,000 per year

Company

hirify.global develops medical and life science instrumentation, in vitro diagnostic solutions, and biotechnology products for clinical and biopharmaceutical markets.

What you will do

• Own integrated cross-functional program plans from proposal through commercial launch and post-launch surveillance.
• Manage stage-gate governance, milestone accountability, gate reviews, deliverables, budgets, risks, dependencies, and recovery plans.
• Lead new product development, sustaining, lifecycle, design change, reliability, cost-down, obsolescence, and end-of-life programs.
• Coordinate R&D, Product Management, Quality, Regulatory, Operations, Supply Chain, Service, Marketing, and Commercial stakeholders.
• Maintain program status reporting, risk registers, critical paths, DHF completeness, and audit readiness.
• Provide portfolio leadership with recommendations on capacity, trade-offs, prioritization, and resource conflicts.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• 7+ years of product development, program management, or project management experience, including 3+ years leading cross-functional programs end to end.
• Product launch experience in regulated medical devices, IVD, diagnostics, or life science instrumentation.
• Working knowledge of stage-gate development, design controls, risk management, ISO 13485, and FDA QMSR quality systems.
• Experience managing new product development and sustaining or lifecycle programs, including design changes and field corrective actions.
• Strong schedule, critical-path, program-tooling, executive reporting, and matrix leadership skills without direct authority.

Nice to have

• PMP, PgMP, or equivalent program management certification.
• Experience with instrumentation, consumables, software combination programs, shared-resource portfolios, design transfer, process validation, or manufacturing scale-up.

Culture & Benefits

• Medical, dental, and vision coverage.
• 401(k) company match, bonus program, paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Collaborative, empowered culture focused on customer centricity, ownership, accountability, innovation, and integrity.
• Lunch and snack marketplaces or subsidized cafeteria at selected Massachusetts and Maine offices.