Project Manager

About the Role

Key Responsibilities

• Lead project planning and scheduling across multiple concurrent workstreams
• Develop and maintain integrated project timelines, including key milestones, dependencies, and risk retirement points
• Coordinate cross-functional teams to align development activities with commercial and operational timelines
• Facilitate resource planning to ensure adequate staffing across functional teams
• Identify resource gaps/overloads, critical-path tasks, and project risks
• Drive timely decision-making through clear communication and status reporting
• Collaborate closely with engineering, quality, regulatory, manufacturing, field service, and marketing stakeholders
• Support project phase-gate reviews and ensure deliverables meet quality and regulatory standards

Requirements

• 5+ years of project management experience in medical devices, biotechnology, or a related regulated industry
• Demonstrated experience managing complex schedules and cross-functional teams
• Strong understanding of product development processes and life cycle management
• Excellent written and verbal communication skills
• Exceptional organizational, analytical, and problem-solving skills
• Proven ability to manage multiple priorities and deadlines in a fast-paced environment
• Proficiency with project management tools

Nice to Have

• PMP certification or formal training in project management methodologies
• Master's degree in Engineering, Business Administration, or related discipline
• Experience working in early-stage medical device startups
• Familiarity with medical device regulations, ISO 13485, and regulatory submission processes (e.g., 510(k))
• Prior experience aligning R&D and commercial teams through launch phases