Project Manager - Class III Medical Implants

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 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. Facilitate cross‑functional project team meetings (R&D, Quality, Regulatory, Manufacturing, Clinical, Marketing). Manage project KPIs, timelines, and resource allocations; escalare risks proactively. 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. 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. 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. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. #J-18808-Ljbffr