Program Manager - Medical Device

Location: Beverly, Massachusetts, United States

Salary: $120,000–$140,000 annually, depending on skills, experience, and qualifications.

Company

hirify.global develops and manufactures medical device products and supports customers through regulated product development and manufacturing programs.

What you will do

• Lead cross-functional internal teams, vendors, suppliers, clinicians, customers, and strategic partners across complex medical device programs.
• Drive product development from feasibility and concept through validation, production transfer, and sustaining manufacturing.
• Manage project budgets, billing, transfer cost of goods sold, schedules, scope, risks, constraints, and mitigation plans.
• Oversee design and process documentation, test fixtures, quality records, change control, traceability, and audit readiness.
• Lead compliance activities covering design controls, DMR/DHF, risk analysis, ISO standards, GMP, FDA, MDR, Health Canada, PMDA, and customer requirements.
• Evaluate new business opportunities, lead quoting and proposal development, and collaborate with Sales on strategic opportunities.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related science or technical field.
• 8+ years of experience in medical devices or a related industry, including 6+ years in project or program management within manufacturing.
• Experience leading high-complexity development programs or multiple projects through prototyping and product launch.
• Knowledge of medical device engineering and manufacturing processes, including drawings, equipment, injection molding, extrusion, catheter manufacturing, assembly, silicone, and plastics.
• Advanced problem-solving experience, including Design of Experiments, critical thinking, Lean, and Six Sigma methods.
• Deep knowledge of ISO 13485, ISO 14001, ISO 14971, GMP principles, 21 CFR 820, and CE design controls.

Nice to have

• Advanced degree or MBA.
• Experience managing team members, training employees, and contributing to performance evaluations.

Culture & Benefits

• Full-time employment with opportunities to mentor engineering staff and develop high-performing teams.
• Collaborative focus on efficiency, innovation, teamwork, and regulatory excellence.
• Travel to other sites as needed for projects.
• Equal opportunity employer committed to diversity and inclusion.