Project Manager (Class III Medical Implants)

TL;DR

Project Manager (Class III Medical Implants): Leading cross-functional teams through the full lifecycle of highly regulated, risk-critical medical device programs with an accent on regulatory alignment, design controls, and commercialization. Focus on driving project planning, execution, and compliance for implantable medical products to ensure they reach the market on time and within budget.

Location: Remote with 20% onsite requirement in Effingham, IL

Company

hirify.global provides expert consulting solutions across the complete product lifecycle for biotech, med device, and pharmaceutical organizations.

What you will do

• Lead end-to-end project management from concept through design, verification, validation, and regulatory submission.
• Develop and maintain integrated project plans, schedules, budgets, and risk registers.
• Facilitate cross-functional project team meetings across R&D, Quality, Regulatory, Manufacturing, and Clinical departments.
• Manage project KPIs, timelines, and resource allocations while proactively escalating risks.
• Drive implementation of design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971.
• Partner with operations and manufacturing teams to develop scalable, validated production processes.

Requirements

• Must be based in the United States
• 5+ years of project management experience in medical devices.
• Strong experience with Class III or implantable medical device development, including PMA or IDE programs.
• Demonstrated familiarity with regulatory frameworks for high-risk medical devices.
• Deep understanding of design controls, risk management, and medical device quality systems.
• Bachelor’s degree in Engineering, Life Sciences, or a related field.

Nice to have

• Master’s degree
• PMP certification

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment for remote and hybrid work.
• Focus on collaborative and entrepreneurial spirit.
• Equal Opportunity Employer with a holistic approach to employee success.