Senior Manufacturing Program Manager responsible for leading site-level regulatory implementation, change control, manufacturing readiness, and cross-functional execution within a regulated manufacturing environment. Job Requirements Bachelor's degree in Engineering. Minimum 7 years of relevant manufacturing, engineering, regulatory, or operations experience. 5+ years of project management, program management, or site execution leadership experience. Project or program management experience within a manufacturing environment. Experience leading site-based implementation of regulated changes. Experience supporting regulatory, quality, engineering, manufacturing, or operations change initiatives. Strong understanding of manufacturing processes and manufacturing execution. Experience with engineering and manufacturing change control. Experience coordinating activities across Manufacturing, Quality, Engineering, Supply Chain, and Operations. Experience managing programs against fixed regulatory deadlines and constrained schedules. Experience developing and maintaining project execution plans, schedules, milestones, and dependencies. Experience identifying execution risks and developing mitigation plans. Preferred Skills Experience with EU MDR or other medical device regulatory implementation programs. Experience in regulated medical device manufacturing. Experience with ECO, MCO, SMECO, or similar engineering and manufacturing change-order processes. Experience supporting audits, inspections, and regulatory readiness activities. Experience with manufacturing master data management. Experience maintaining manufacturing process planning documentation. Experience supporting machining, metal finishing, and assembly operations. Experience developing or maintaining manufacturing labor standards. Experience implementing manufacturing process improvements related to quality, delivery, and cost. Job Responsibilities Lead site-level implementation activities for regulatory and manufacturing change programs. Translate program-level implementation requirements into executable site plans and schedules. Own site execution plans, milestones, dependencies, and implementation timelines. Coordinate execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations. Manage engineering and manufacturing change activities, including ECO, MCO, SMECO, or equivalent processes. Ensure required documentation updates, system changes, and manufacturing readiness activities are completed according to program requirements. Track project milestones, execution status, risks, constraints, and dependencies. Develop and implement mitigation plans for schedule, capacity, and execution risks. Escalate implementation issues and dependency risks affecting regulatory or manufacturing deadlines. Maintain documentation and traceability for audits, inspections, and internal reviews. Ensure site activities follow established regulatory implementation and change-control processes. Coordinate entry and maintenance of master data for assigned product lines. Provide manufacturing support for machining, metal finishing, and assembly processes. Maintain manufacturing process planning documentation and associated labor standards. Identify and implement manufacturing process improvements affecting part quality, schedule performance, and manufacturing cost. Track site implementation readiness and regulatory deliverables through completion.

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