Engineering Project Manager
Job Summary:
We are seeking a Project Manager to lead cross-functional teams through the full product development lifecycle, from concept through commercialization within the R&D Department. This role is responsible for project planning, schedule management, risk mitigation, and ensuring compliance with design control and quality system requirements. The NPD Project Manager will partner closely with Engineering, Marketing, Regulatory, Quality, Operations, Clinical, and Supply Chain to deliver innovative spinal implant and instrument solutions on time and within scope. Occasional travel may be required.
Principal Duties and Responsibilities:
• Leads the planning of new product development projects using structured phase-gate and design control processes common to the medical device industry.
• Develops and maintains detailed Gantt charts, project schedules, resource plans, and critical path analyses.
• Facilitates cross-functional collaboration across Engineering, Marketing, Regulatory, Quality, Operations, Clinical, Testing, and Supply Chain to ensure alignment on requirements, deliverables, and timelines.
• Leads project meetings, including kickoffs, weekly status reviews, technical reviews, and phase-gate approvals; prepares agendas, documents minutes, assigns action items, and drives accountability.
• Tracks project progress, identifies risks, and implements mitigation strategies to ensure successful execution.
• Supports the completion of project documentation that is accurate, and compliant within the Design History File (DHF).
• Supports the development and refinement of user needs, product requirements, and system specifications by coordinating input from surgeons, marketing, and engineering teams.
• Coordinates with Regulatory Affairs to ensure project deliverables support global submissions and compliance requirements.
• Works with Operations and Supply Chain to support manufacturing readiness, pilot builds, process validation, and launch planning.
• Prepares and presents project updates, dashboards, and risk assessments to leadership and executive stakeholders.
• Manages multiple concurrent projects and adjusts plans to meet evolving business priorities.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities):
Strong working knowledge of medical device product development, including design control, risk management, and quality system requirements.
• Demonstrated ability to lead cross-functional teams and influence without direct authority, consistent with practices at leading device manufacturers.
• Demonstrated creativity and ability to take actions in solving problems and making decisions in a dynamic and evolving environment.
• Proficiency in developing and managing complex project schedules, resource plans, and risk registers.
• Ability to communicate effectively with technical and non-technical stakeholders, including surgeons, engineers, executives, and external partners.
• Strong organizational skills with the ability to manage multiple high-complexity projects simultaneously.
• Experience preparing and delivering executive-level presentations and project status reports.
• Proficiency with MS Project, Smartsheet, or equivalent project management tools; strong skills in Microsoft Office Suite.
• Familiarity with manufacturing processes, design for manufacturability, and supply chain considerations for implant and instrument systems.
• Experience in a regulated medical device environment (Class II/III preferred)
Education/Experience Requirements:
• Minimum B.S. degree in Engineering, Project Management, Business, or related field.
• 3+ years of experience in project management, preferably within the medical device industry or other regulated product development environments.
• Experience managing cross-functional teams and complex product development projects.
• PMP certification or equivalent is a plus.
Please visit Highridgemedical.com for additional information.
