PLM Manager

The Product Lifecycle Management teamensures that medical devices and components move through each lifecycle phasewith clear ownership, controlled product data, regulatory compliance, productquality, operational efficiency, and cost discipline. As PLM Manager, you willlead day-to-day lifecycle governance and coordinate Engineering, NPI,Operations, Quality and Regulatory, Supply Chain, IT, Commercial teams, andcustomers around a single product record and stage-gate process. You are a structured, relationship-focusedmanager who is equally comfortable facilitating customer and cross-functionalreviews, challenging incomplete evidence, coaching team members, and drivingactions to closure. You combine technical depth with business judgment and caninfluence without relying on direct authority. Key responsibilities 1. Lifecycle governance and program execution · Implement the PLM operatingmodel, lifecycle stage gates, decision rights, templates, and KPIs establishedby the PLM Director. · Coordinate lifecycle activitiesfrom concept and feasibility through design transfer, commercial production,sustaining engineering, product rationalization, and end-of-life. · Chair or facilitatecross-functional lifecycle reviews. Confirm entry and exit criteria, evidencereadiness, decisions, risks, owners, and closure dates. · Maintain integrated programvisibility across customer requirements, product data, technical risks,manufacturing readiness, regulatory commitments, cost, and schedule. · Escalate material risks,unresolved cross-functional constraints, and decisions outside delegatedauthority with clear options and recommendations. 2. NPI, design transfer, and manufacturing readiness · Partner with customer R&D,NPI, Quality and Regulatory, Manufacturing, Automation, Tooling, and SupplyChain to execute robust design transfer and production readiness. · Ensure manufacturability,scalability, risk controls, process capability, validation readiness, andsupply continuity are addressed before release to commercial manufacturing. · Coordinate applicablequalification and validation activities, including IQ, OQ, and PQ, and ensuredeviations and open items are controlled before gate approval. · Ensure handover from NPI toOperations includes approved specifications, BOMs, routings, control plans,risk files, validation evidence, training, capacity assumptions, and ownershipof remaining actions. 3. Product data, configuration, and change control · Own the operationaleffectiveness of product structures and lifecycle workflows, including partnumbering, item master data, BOM integrity, document status, and engineeringchange coordination. · Coordinate ECR and ECOassessment and implementation across Engineering, Quality, Regulatory,Operations, Supply Chain, IT, and customers. · Ensure changes include impactassessment for validation, risk management, regulatory submissions, inventorydisposition, supplier readiness, customer approval, and effective-date control. · Improve PLM procedures, workinstructions, templates, user guidance, and data-quality controls to strengthenadoption and audit readiness. 4. Sustaining engineering and lifecycle value · Lead a controlled portfolio ofsustaining engineering, yield improvement, cost reduction, reliability,capacity, automation, and product optimization initiatives. · Drive fact-based prioritizationusing customer impact, compliance risk, quality performance, capacity, cost,margin, and resource requirements. · Coordinate product performancereviews covering yield, scrap, defects, COGS, margin, delivery, change aging,and lifecycle risks. · Lead component obsolescence,alternate-source, product rationalization, and end-of-life planning, includingcustomer communication and controlled phase-out. 5. Quality, regulatory, and risk management · Ensure lifecycle executionaligns with the company QMS, customer requirements, design control, changecontrol, and applicable medical-device regulations and standards. · Coordinate maintenance oflifecycle records, including DHF and DMR content where applicable, riskmanagement files, validation evidence, and traceability of product changes. · Partner with Quality andRegulatory to assess complaint, nonconformance, CAPA, audit, and post-marketinputs that may require product or process changes. · Support internal, customer, andregulatory audits by ensuring records are current, traceable, approved, andreadily retrievable. 6. PLM systems, digital workflow, and adoption · Translate business needs intoclear PLM system requirements, prioritized enhancements, user stories,acceptance criteria, and deployment readiness. · Coordinate user acceptancetesting, training, feedback, change communication, and post-release follow-upwith IT and business process owners. · Drive standardization andintegration between PLM, ERP, QMS, and related engineering systems whilemaintaining data ownership and controls. · Use workflow metrics and userfeedback to reduce manual work, improve data quality, shorten cycle time, andincrease process adoption. 7. Customer and stakeholder leadership · Act as the operationallifecycle liaison for assigned customers and programs, establishing clearreview cadences, commitments, and escalation paths. · Build trusted relationshipsacross functions and sites. Resolve ownership gaps and align competingpriorities through evidence, risk, and business impact. · Prepare concise executiveupdates and customer communications covering lifecycle status, decisions,risks, financial impact, and recovery actions. 8. Team leadership and capability building · Lead, coach, and develop PLM,product lifecycle engineering, change-control, or program resources as assignedacross Singapore and Malaysia. · Set clear objectives, workloadpriorities, capability plans, and performance indicators aligned withdepartment goals. · Build practical competence instage-gate governance, design transfer, configuration management, riskmanagement, customer communication, and financial thinking. · Create a…