Project Manager - Class III Medical Implants (Medical Devices)

Location: United States; remote working with 20% onsite in Effingham, Illinois

Company

hirify.global provides consulting solutions across the biotech, medical device, and pharmaceutical product lifecycle, including regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology.

What you will do

• Lead end-to-end project management for Class III implantable medical device programs from concept through design, verification, validation, clinical evaluation, regulatory submission, and commercialization.
• Develop and maintain integrated project plans, schedules, budgets, risk registers, KPIs, and resource allocations.
• Coordinate cross-functional teams across R&D, Quality, Regulatory, Manufacturing, Clinical, and Marketing.
• Oversee design controls, including user needs, design inputs and outputs, verification, validation, and design transfer.
• Coordinate manufacturing, supplier quality, process validation, and device master record development.
• Communicate project status, risks, milestones, and decisions to executives and stakeholders.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• 5+ years of project management experience in medical devices, preferably involving Class III or implantable devices.
• Experience with PMA preparation, IDE clinical studies, or comparable high-risk medical device programs.
• Strong knowledge of design controls, risk management, and medical device quality systems, including 21 CFR 820, ISO 13485, and ISO 14971.
• Experience leading cross-functional teams and managing complex product development programs.
• Expertise with project management tools such as MS Project, Smartsheet, or similar.

Nice to have

• Master’s degree.
• PMP certification.
• Experience with FDA, EU MDR, biocompatibility, sterilization, packaging, durability, and global regulatory pathways.

Culture & Benefits

• Remote working model with 20% onsite work in Effingham, Illinois.
• Hybrid collaboration may be arranged for employees located within a reasonably short commute of a hirify.global office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Work environment encourages innovation, collaboration, entrepreneurship, and authentic participation.
• Applications are personally reviewed by the recruitment team without AI screening tools.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome for their application.