Engineering Manager, Advanced Operations

🌍 Remote, USA 🎯 Full-time πŸ• Posted Recently

Job Description

As the Advanced Operations & Manufacturing Engineering Manager for New Technology & Product Introduction, you will lead a team responsible for transitioning new medical devices from design to full-scale production and sustaining the technology post-launch. You will work across multiple Stryker sites and collaborate with R&D, Quality, Regulatory, and Operations to ensure manufacturability, scalability, compliance, and on-time delivery of high-quality products. What you will do: Leadership & Talent Development: β€’ Attract, develop, retain, and engage top engineering talent; drive professional growth and high performance. β€’ Provide coaching and actionable feedback; set clear performance objectives. β€’ Promote a culture of diversity, inclusion, belonging, continuous improvement, and operational excellence. β€’ Distill department strategy into objectives for direct reports. Project & Program Leadership: β€’ Lead high-complexity NPI projects, including planning, budgeting, timelines, resourcing, and risk management. β€’ Make independent decisions on program-level issues and remove barriers to execution. β€’ Communicate project status, risks, and mitigation plans to senior leadership. β€’ Partner with R&D to influence design decisions that improve manufacturability and cost. Technical Execution & Manufacturing Readiness: β€’ Oversee engineering deliverables for new technology and product introduction programs. β€’ Ensure project milestones are met on time, within budget, and to quality standards. β€’ Lead development and optimization of manufacturing processes, tooling, and equipment. β€’ Ensure robust process capability, scalability, and readiness for volume production. β€’ Drive Design for Manufacturability (DFM), risk assessments, and process validation (IQ/OQ/PQ). β€’ Implement and promote lean manufacturing and Six Sigma methodologies. β€’ Collaborate with Quality, Regulatory, and Advanced Technology to ensure compliance with FDA, ISO, and internal standards. β€’ Identify and implement NPI best practices across programs. Med Device Compliance: β€’ Lead cross-functional teams in launching new technologies and products that meet all regulatory requirements. β€’ Provide direction on design controls for new and existing processes/products. β€’ Review and approve (or delegate) program- and project-specific documentation and technical deliverables. Minimum Qualifications: β€’ Bachelor’s degree in Engineering (Materials Science background strongly preferred) β€’ 8+ years relevant experience β€’ 3+ years people management experience β€’ Proven new product introduction experience in a regulated industry (medical device preferred) β€’ Strong knowledge of DFM, process validation, and quality systems (FDA, ISO 13485) Preferred Qualifications: β€’ Experience with investment casting or metal injection molding β€’ Strong performance coach and talent developer β€’ Experience executing performance and talent management strategies β€’ Ability to communicate complex plans and technical information to senior leadership β€’ Track record of delivering programs on time, on quality, and on budget Apply tot his job

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