Project Manager

Job Title : Project Manager

Location : Andover MA (Onsite)

Employment Type: 12 Months

Key Responsibilities

• Lead complex NPD programs (robotics, electromechanical systems, embedded software, cloud applications)
• Manage project execution: schedule, budget, risks, and issues
• Lead cross-functional teams across engineering, quality, regulatory, manufacturing, and commercial
• Apply Agile & DevOps practices
• Oversee cloud-based/connected solutions in regulated environments
• Ensure compliance with design controls and QMS
• Support DHF and phase review processes
• Provide executive-level reporting
• Drive product lifecycle from concept to launch (orthopaedics focus)
• Manage sustaining engineering, enhancements, and cost reduction
• Maintain RAID logs
• Coordinate teams and resource allocation

Key Requirements

• Education: Bachelor s/Master s in Biomedical, Mechanical, or related field
• Experience: 10+ years (5+ years in medical device project leadership)
• Certifications: PMP / PRINCE2 / Agile PM
• Technical Skills: MS Office, project management tools, CAD documentation
• Domain Knowledge: Medical device design controls (21 CFR 820.30)
• Soft Skills: Strong communication, problem-solving, adaptability

Required Qualifications

• 10+ years in program/project management
• Experience in MedTech/medical device industry
• Experience with robotics, electromechanical systems, IoT, or connected systems
• Strong understanding of FDA-regulated product development
• Bachelor s degree in Engineering or related field