via Workday
$120K - 160K a year
Lead engineering team to transition new medical devices from design to production, ensuring manufacturability, compliance, and on-time delivery.
Bachelor's in Engineering, 8+ years relevant experience including 3+ years management, expertise in regulated industry product introduction and quality systems.
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: • Attract, develop, retain, and engage top engineering talent; drive professional growth and high performance. • Provide coaching and actionable feedback; set clear performance objectives. • Promote a culture of diversity, inclusion, belonging, continuous improvement, and operational excellence. • Distill department strategy into objectives for direct reports. Project & Program Leadership: • Lead high-complexity NPI projects, including planning, budgeting, timelines, resourcing, and risk management. • Make independent decisions on program-level issues and remove barriers to execution. • Communicate project status, risks, and mitigation plans to senior leadership. • Partner with R&D to influence design decisions that improve manufacturability and cost. Technical Execution & Manufacturing Readiness: • Oversee engineering deliverables for new technology and product introduction programs. • Ensure project milestones are met on time, within budget, and to quality standards. • Lead development and optimization of manufacturing processes, tooling, and equipment. • Ensure robust process capability, scalability, and readiness for volume production. • Drive Design for Manufacturability (DFM), risk assessments, and process validation (IQ/OQ/PQ). • Implement and promote lean manufacturing and Six Sigma methodologies. • Collaborate with Quality, Regulatory, and Advanced Technology to ensure compliance with FDA, ISO, and internal standards. • Identify and implement NPI best practices across programs. Med Device Compliance: • Lead cross-functional teams in launching new technologies and products that meet all regulatory requirements. • Provide direction on design controls for new and existing processes/products. • Review and approve (or delegate) program- and project-specific documentation and technical deliverables. Minimum Qualifications: • Bachelor’s degree in Engineering (Materials Science background strongly preferred) • 8+ years relevant experience • 3+ years people management experience • Proven new product introduction experience in a regulated industry (medical device preferred) • Strong knowledge of DFM, process validation, and quality systems (FDA, ISO 13485) Preferred Qualifications: • Experience with investment casting or metal injection molding • Strong performance coach and talent developer • Experience executing performance and talent management strategies • Ability to communicate complex plans and technical information to senior leadership • Track record of delivering programs on time, on quality, and on budget
This job posting was last updated on 12/10/2025