Bachelor's degree in Engineering, Life Sciences, or related field; Master's degree or PMP certification is a plus.
5+ years of project management experience in medical devices, especially Class III or implantable medical devices.
Familiarity with regulatory frameworks for high-risk medical devices is essential.
Experience in cross-functional leadership and managing complex product development processes.
In-depth knowledge of design controls, risk management, and quality systems in the medical device sector.
Responsibilities
Lead the entire project lifecycle from concept through to regulatory submission and market launch.
Develop and maintain comprehensive project plans, schedules, and budgets while managing risks.
Facilitate effective communication and coordination among cross-functional teams including R&D, Quality, and Marketing.
Manage key project performance indicators and resources, proactively addressing any risks that arise.
Oversee the implementation of design controls in compliance with regulatory standards and ensure product requirements are met.
Collaborate with manufacturing teams to create scalable production processes that adhere to regulatory standards.
Act as the main point of contact for project-related inquiries, communicating updates to stakeholders.
Benefits
Remote work flexibility with 20% required onsite presence in Effingham, IL.
Opportunities for professional development and potential for advanced certifications in project management.
Full Job Description
The Project Manager for Class III Medical Implants is responsible for leading cross-functional teams through the full lifecycle of highly regulated, risk-critical medical device programs. This role drives project planning, execution, regulatory alignment, and commercialization activities to ensure safe, effective, and compliant implantable medical products reach the market on time and within budget.
Key Responsibilities
1. Project Leadership & Execution
Lead end-to-end project management from concept through design, verification/validation, clinical evaluation, regulatory submission activities including PMA preparation, IDE clinical studies, and global regulatory pathways (FDA, EU MDR) where applicable.
Develop and maintain integrated project plans, schedules, budgets, and risk registers.
Manage project KPIs, timelines, and resource allocations; escalate risks proactively.
2. Design & Development Oversight
Drive implementation of design controls compliant with 21 CFR 820, ISO 13485, and ISO 14971 risk management requirements: user needs, design inputs/outputs, verification, validation, design transfer.
Collaborate with engineering teams to ensure design requirements are met for implantable use (biocompatibility, sterilization, packaging, durability).
Support planning and execution of clinical studies or physician evaluations when required.
3. Manufacturing & Supply Chain Coordination
Partner with operations/manufacturing teams to develop scalable, validated production processes.
Ensure suppliers meet quality and regulatory standards for implantable components.
Support process validation (IQ/OQ/PQ) and device master record (DMR) creation.
4. Stakeholder & Communication Management
Communicate project status, milestones, risks, and decision needs to executives and key stakeholders.
Serve as the primary point of contact for project-related inquiries.
Qualifications
Education
Bachelor's degree required (Engineering, Life Sciences, or related field preferred).
Master's degree or PMP certification a plus.
Experience
5+ years of project management experience in medical devices; Class III or implantable medical device development experience strongly preferred, including PMA or IDE programs.
Demonstrated familiarity with regulatory frameworks for high-risk medical devices.
Experience in cross-functional leadership and complex product development.
Skills & Competencies
Deep understanding of design controls, risk management, and medical device quality systems.
Excellent organizational and planning skills.
Strong interpersonal and communication skills.
Ability to manage ambiguity and drive decision-making.
Expertise using project management tools (MS Project, Smartsheet, or similar).
**Remote working with 20% onsite in Effingham, IL
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
About ProPharma Group
ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
