Overview In this role you will design and refine manufacturing processes for safe, high-quality medical devices. You'll lead the development and qualification of tooling, fixtures, and equipment, while supporting both new product introductions and sustaining efforts. You will collaborate across teams to resolve production challenges, drive continuous improvement, and ensure compliance with quality systems. This is an impact-driven position focused on patient safety and manufacturing excellence.
Responsibilities- Design, develop, document, and improve manufacturing processes and operations for safety, quality, and performance of medical devices
- Design, procure, and oversee fabrication of tooling, fixtures, and manufacturing equipment with safety compliance
- Lead equipment and process qualification, verification, and validation activities
- Troubleshoot manufacturing issues related to safety, quality, delivery, productivity, and cost
- Design and coordinate tests, analyze data, and communicate recommendations
- Support new product development and sustaining efforts through technology development, process studies, and reporting
- Participate in design control activities including FMEA, design reviews, and change management
- Collaborate with operators, technicians, engineers, and cross-functional teams to improve performance
- Develop, validate, and implement manufacturing equipment and processes with opportunities for continuous improvement
- Support production goals through project planning, scheduling, execution, and documentation
- Train and provide guidance to operators and technicians
- Coordinate with suppliers and external partners to support process and product improvements
- Analyze statistical data to identify trends and inform business decisions
- Demonstrate commitment to patient safety, product quality, and compliance with Stryker's QMS and regulatory requirements
Key requirements- Bachelor's degree in Mechanical Engineering
- 2+ years of engineering experience in manufacturing
- Experience designing and developing tooling and fixtures for manufacturing
- Experience reading and interpreting engineering drawings using SolidWorks or equivalent
- Ability to perform statistical, geometric, and mathematical analyses
- Experience supporting equipment and process validation
- Strong troubleshooting and root cause analysis skills
- Strong collaboration and communication skills
- team collaboration
- clear communication
- problem solving
- SolidWorks (or other design software)
- statistical analysis (e.g., Minitab or similar)
- Six Sigma, process improvement
