Consultant, Engineering Project Manager, Medical Devices Summary Our client, an innovative global leader within medical devices, is seeking an Engineering Project Manager to manage and execute cross-functional technical focused projects that deliver exceptional supplier performance and ensure optimal operational readiness across the company's supply chain. This role will be accountable for initiatives and projects within three main workstreams: strategic sourcing execution, supplier capability development and improvement, and new product introduction (NPI) supplier readiness. Requirements Manage and own high-impact supplier-related initiatives, delivering on cost, quality, compliance, and timeline objectives. Lead structured meetings with clear actions and accountability, aligning internal stakeholders (i.e. Procurement, Quality, Regulatory, R D) and external suppliers to drive complete execution on project priorities/milestones, technical, quality, regulatory, and business requirements. Produce and maintain detailed project plans, managing deliverables and timelines across departments. Strategic Sourcing Execution Workstream Produce supplier capacity assessments and technical capability evaluations in collaboration with Sourcing and Procurement teams, ensuring supplier alignment with clients global sourcing strategy, cleaning and biocompatibility requirements, FDA, ISO 13485, and global regulatory requirements. Identify and manage legacy product transfer projects to new or existing suppliers that improve clients ability to deliver exceptional customer service and optimize its supply chain for growth and cost savings. Act as technical project lead throughout product transfers to provide technical support and proactively identify opportunities to pull in timelines and reduce project risk by reviewing process validations, manufacturing documentation, etc. Establish and manage strong working relationships with critical and strategic suppliers. Supplier Capability & Performance Optimization Workstream Monitor and analyze supplier KPIs including delivery performance, nonconformance trends, and cost performance. Produce and execute data-driven performance improvement projects to enhance supplier quality, increase on-time delivery, expand capacity, and reduce product costs. Deliver should-cost analysis and manufacturing process optimization for components requiring machining, finishing, and assembly to enable cost reduction and improved manufacturability. Evaluate supplier-related risks (financial, capacity, delivery) and deploy mitigation projects and/or strategies to deliver uninterrupted supply chain performance. New Product Introduction (NPI) Implementation Workstream Own and deliver supplier readiness for new product launches, ensuring ability to meet product manufacturing capabilities, DFM, cost targets, capacity expectations, and needed deliverables. Create and maintain technical documentation including drawings, inspection plans, process routers, and manufacturing procedures per QMS and FDA 21 CFR Part 820 requirements. Nice to Have Experience with MRP / ERP systems is preferred. Experience with Smartsheet software is preferred. Requirements Bachelor's degree in engineering required. 5+ years of engineering experience and 2+ years of managing projects as an accountable project lead. Proven track record and ability to lead cross-functional teams and deliver supplier-facing projects in complex, regulated environments. Proficiency in MS Office Applications. Proficiency in CAD software Project management and operations expertise Broad knowledge of operations and supply chain processes with strong technical expertise in process validation, design verification activities and risk files. Competency in financial concepts such as building a business case and managing a project budget. Strong understanding of medical device regulations including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and MDSAP Direct experience with PPAP, FAI, and process validation (IQ/OQ/PQ). Competence with drafting standards and geometric dimensioning and tolerancing Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions Proficient with Statistical Process Control concepts, process development, process validations, inspection methodology Familiarity with cleanroom manufacturing, biocompatibility testing, sterilization validation, and traceability requirements. Competent with executive-level and stakeholder management communication in a global company. Terms & Start Onsite 3 days/week in Westminster, CO 6-month Contract to Hire, high likelihood of converting to Full-Time Start ASAP Travel up to 15%
Job ID: 479737425
Originally Posted on: 6/4/2025
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