Sr. Project Manager

About us

Position Summary

Key Responsibilities

• Lead and coordinate assigned medical device projects, including development activities and manufacturing transfer efforts for components, sub-assemblies, and finished devices.
• Lead end-to-end program lifecycle including planning, execution, monitoring, and closure
• Transfers to another location, within the network
• Intercompany collaboration on programs
• Develop, maintain, and update project schedules, work breakdown structures, task plans, headcount planning and risk documentation to support effective execution and prioritization of project activities.
• Facilitate collaboration across engineering, quality, operations, and other functional teams to drive timely achievement of project deliverables and milestones.
• Monitor project performance with respect to schedule, cost, technical challenges, and risk exposure, with resource planning, and prepare clear status updates for internal leadership and external stakeholders.
• Identify potential project-level risks and issues early, and implement appropriate mitigation strategies, corrective actions, or preventive measures as needed.
• Ensure required Design History File documentation is created and maintained in compliance with internal procedures and applicable FDA (21 CFR 820) and ISO 13485 requirements.
• Ensure that cost is understood going into operations ramps.
• Lead problem-solving initiatives and corrective actions
• Maintain risk registers and contingency plans
• Apply Lean, Six Sigma, and continuous improvement methodologies
• Support project teams in defining, documenting, and maintaining product requirements, verification activities, and test plans throughout the development lifecycle.
• Serve as the primary point of contact for customers on assigned projects, coordinating routine communications, meetings, and site visits as appropriate.
• Coordinate with functional and site leadership to align internal resources and capacity in support of project objectives and delivery timelines

Must Have

• Minimum BS in a relevant engineering discipline
• At least 5 years of experience within the medical device industry
• Minimum 5 years of experience in project / program management of medical device development.
• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
• Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
• Provide clear, data-driven program updates (KPIs, risks, milestones) to executive leadership
• Facilitate decision-making and escalation of critical issues
• Must have proficiency in MS Project and other MS Office software.
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
• Willingness to travel, if required.

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