Project Manager (NPD, Medical Device)

Location: Andover, MA OR Oklahoma City, OKExperience: 10+ YearsVisa: Open to Any VisaKey ResponsibilitiesLead complex NPD programs (robotics, electromechanical systems, embedded software, cloud applications)Manage project execution: schedule, budget, risks, and issuesLead cross-functional teams across engineering, quality, regulatory, manufacturing, and commercialApply Agile & DevOps practicesOversee cloud-based/connected solutions in regulated environmentsEnsure compliance with design controls and QMSSupport DHF and phase review processesProvide executive-level reportingDrive product lifecycle from concept to launch (orthopaedics focus)Manage sustaining engineering, enhancements, and cost reductionMaintain RAID logsCoordinate teams and resource allocationKey RequirementsEducation: Bachelor’s/Master’s in Biomedical, Mechanical, or related fieldExperience: 10+ years (5+ years in medical device project leadership)Certifications: PMP / PRINCE2 / Agile PMTechnical Skills: MS Office, project management tools, CAD documentationDomain Knowledge: Medical device design controls (21 CFR 820.30)Soft Skills: Strong communication, problem-solving, adaptabilityRequired Qualifications10+ years in program/project managementExperience in MedTech/medical device industryExperience with robotics, electromechanical systems, IoT, or connected systemsStrong understanding of FDA-regulated product developmentBachelor’s degree in Engineering or related field