Project Manager - Class III Medical Implants

Key Responsibilities

• 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.
• 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.
• 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.
• 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

• Bachelor’s degree required (Engineering, Life Sciences, or related field preferred).
• Master’s degree or PMP certification a plus.
• 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).