Engineering Manager, Advanced Operations

Stryker•Mahwah, NJ

2d•Hybrid

About The Position

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.

Requirements

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)

Nice To Haves

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

Responsibilities

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.
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.
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.
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.