Project Manager (Medical Devices)

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.