Project Manager (Medical Devices)

TL;DR

Project Manager (Medical Devices): Leading cross‑functional teams through the full lifecycle of highly regulated, risk‑critical Class III medical implant programs with an accent on regulatory alignment and commercialization. Focus on driving design controls, managing PMA/IDE submissions, and ensuring compliance with FDA and EU MDR standards.

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

Company

hirify.global provides customizable consulting solutions to biotech, med device, and pharmaceutical organizations to de-risk and accelerate high-profile drug and device programs.

What you will do

• Lead end‑to‑end project management from concept through design, verification/validation, and regulatory submission (PMA, IDE).
• Develop and maintain integrated project plans, schedules, budgets, and risk registers.
• Implement design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971 risk management requirements.
• Collaborate with engineering to ensure requirements for biocompatibility, sterilization, and durability are met.
• Partner with manufacturing teams to develop scalable, validated production processes (IQ/OQ/PQ).
• Communicate project status, milestones, and risks to executives and key stakeholders.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 5+ years of project management experience in medical devices, specifically with Class III or implantable devices.
• Demonstrated experience with PMA or IDE programs and high-risk regulatory frameworks.
• Deep understanding of design controls and medical device quality systems.
• Proficiency in project management tools such as MS Project or Smartsheet.

Nice to have

• Master’s degree.
• PMP certification.

Culture & Benefits

• Support for remote working with a focus on purposeful in-person collaboration.
• Strong commitment to diversity, equity, and inclusion.
• Collaborative and entrepreneurial work environment.
• Personal application review process without the use of AI screening tools.