Position Overview: 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. Essential Job Functions: - 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.
Qualification Requirements: - Bachelor’s Degree in Engineering or related field;
- 5+ years of Program/Project Management with 3+ years within medical device manufacturing,
- contract manufacturing and/or regulated manufacturing environment;
- NPI project experience a plus
Other Skills & Abilities: 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. PHYSICAL DEMANDS While performing the duties of this job, the employee is regularly required to sit and/or stand for long periods at the operator’s station and walk from and to various operators’ stations. The employee is frequently required to use hand, finger or feel, and reach with hands and arms. The employee is required to hold small and large parts with fingers while measuring the part with but not limited to caliper, micrometer, gage pins, thread plug and ring gages, depth gage and height gage. The duties required continuous mental or visual attention and ability to handle short and long cycle repetitive work or diversified operations requiring constant alertness. The employee is required to complete and file the following forms but not limited to certificate of conformance router/work orders, packing list, QI sheet and shipping paper. The employee must frequently lift and/or move up to 20 pounds as well as occasionally lift and move up to 50 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. Elite offers competitive pay and benefits along with the opportunity to use and expand your skills and talents in a great team environment. Marle is an Equal Opportunity Employer.
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