Technical Program Manager

Marle•Bartlett, TN

9d•Onsite

About The Position

The purpose of this position is to serve as the primary customer advocate and internal leader responsible for the successful execution of medical device manufacturing programs from quotation through production, product launch, and lifecycle management. This role coordinates cross-functional teams to ensure customer requirements are met while achieving Marle Elite requirements.

Requirements

Bachelor’s Degree in Engineering or related field
5+ years of Program/Project Management
3+ years within medical device manufacturing, contract manufacturing and/or regulated manufacturing environment
NPI project experience a plus
Ability to work independently with minimal supervision.
Ability to communicate with all plant personnel
working knowledge of Class II and Class III medical devices, implantable devices, orthopedic devices, surgical instruments, ERP systems, Microsoft Project/Smartsheet/Jira.

Responsibilities

Serve as the primary point of contact for assigned customers; develop and maintain strong customer relationships through proactive communication and responsiveness.
Lead customer meetings, business reviews, project status updates, and escalation management; lead program launch activities including transfer-to-production, validation, and commercialization efforts.
Ensure customer expectations are clearly communicated and understood throughout the organization; coordinate activities across Engineering, Production, Quality and Purchasing.
Drive customer satisfaction and support customer retention and growth initiatives; ensure programs meet customer requirements, timelines, and financial objectives.
Manage multiple customer programs simultaneously from concept through commercialization and production.
Develop and maintain comprehensive program plans, schedules, milestones, budgets, and risk registers.
Facilitate decision-making and issue resolution across functional teams.
Lead New Product Introduction (NPI) projects by managing design for Manufacturability (DFM) and Design for Assembly (DFA) reviews, ensuring completion of process development, validation, and production readiness activities, and tracking and reporting project milestones during product development and launch phases.
Ensure regulatory compliance, support customer and regulatory audits, participate in risk management activities and ensure deliverables meet all regulatory and quality standards.
Support quotation and pricing activities, track program costs, capital expenditures, and project budget, and identify opportunities for margin improvement and cost reduction.
Manage customer change orders and scope modifications, assess impact of changes on cost, schedule, quality, and regulatory requirements and ensure proper documentation and implementation of changes.
Identify program risks and develop mitigation plans, escalate critical issues to leadership as appropriate and lead cross-functional problem-solving activities.
Monitor supplier performance affecting program execution and support qualification of new suppliers when required.
Track and communicate On-Time Delivery (OTD), program profitability, launch milestones, CAPA effectiveness, validation progress, quality performance and customer satisfaction metrics.
Drive accountability for commitments and project deliverables, facilitate collaboration among technical, quality, and operational teams, mentor junior project coordinators and project managers as assigned and promote a culture of customer focus, continuous improvement, and operational excellence.
Follow Marle’s safety and environmental procedures.
Follow written and verbal directions from manager and/or company officers.
Perform non-routine tasks assigned by manager and/or company officers.