Senior Program Manager (Medical Devices)

Location: Round Lake, Illinois, United States; flexible workplace policy with a required minimum number of onsite days per week

Salary: $152,000–$209,000 annually, plus potential discretionary bonuses

Company

hirify.global develops healthcare products and technologies focused on saving and sustaining lives.

What you will do

• Lead complex infusion pump programs across new product development, software and firmware releases, sustaining engineering, compliance, cost improvement, and product obsolescence.
• Own program scope, schedules, budgets, resources, quality, risks, and delivery from initiation through closeout.
• Direct cross-functional teams across engineering, manufacturing, regulatory, quality, commercial, service, supply chain, and external partners.
• Build integrated program plans covering dependencies, critical paths, milestones, resource allocation, and launch readiness.
• Establish governance, lead reviews and decision forums, and escalate and resolve complex program issues.
• Communicate status, risks, budgets, and recovery plans to senior leadership while ensuring design-control, quality-system, and regulatory compliance.

Requirements

• Bachelor’s degree in engineering, computer science, life sciences, business, or a related field with 10+ years of relevant experience, or a master’s degree with 8+ years of relevant experience.
• At least 6 years of progressive project or program management experience leading complex cross-functional programs in regulated industries.
• Experience with electromechanical medical devices, infusion systems, connected products, or other safety-critical technologies.
• Knowledge of medical device development, systems engineering, hardware and software development, verification and validation, design controls, and change management.
• Working knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62304, and applicable medical device standards.
• Applicants must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• PMP, PgMP, or equivalent certification.

Culture & Benefits

• Flexible workplace policy with required onsite collaboration days.
• Medical, dental, life, disability, and business travel accident insurance.
• 401(k) retirement plan with company matching and employee stock purchase plan.
• Paid time off, holidays, family and medical leave, and paid parental leave.
• Educational assistance, commuting benefits, childcare benefits, and employee assistance programs.