Project Manager - Class III Medical Implants

Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. 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. Facilitate cross‑functional project team meetings (R&D, Quality, Regulatory, Manufacturing, Clinical, Marketing). 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 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. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***