Senior Manufacturing Engineer
About The Position
Support the ongoing manufacturing of medical devices by designing, documenting, and improving manufacturing processes and operations that ensure product safety, quality, and performance. Lead process qualification, verification, and validation activities to support manufacturing operations and regulatory compliance. Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost. Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements. Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations. Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting. Participate in risk management and design control activities, including FMEA and design reviews. Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance. Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation. Evaluate and implement process or product alternatives to optimize manufacturing performance. Provide technical guidance and training to operators and technicians. Collaborate with suppliers and external partners to support equipment, process, and product initiatives. Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.
Requirements
- Bachelor's degree in Engineering.
- 2+ years of relevant experience supporting manufacturing processes and operations in a production environment.
- Experience conducting process, equipment, or product qualification, verification, and validation activities.
- Experience troubleshooting manufacturing, process, or quality-related issues and implementing effective solutions.
- Experience designing, developing, or supporting manufacturing equipment, tooling, and fixtures.
- Ability to create, read, and interpret engineering drawings using standard engineering software.
- Strong analytical and problem-solving skills, including statistical, geometric, and mathematical analysis.
- Ability to manage technical responsibilities with limited supervision.
Nice To Haves
- Experience within the medical device industry or another regulated manufacturing environment.
- Proficiency with Minitab or similar statistical software.
- Experience participating in design control activities, including risk analysis and FMEA.
- Experience selecting suppliers and assessing supplier capabilities and performance.
- Experience supporting materials testing, process studies, and manufacturing investigations.
Responsibilities
- Support the ongoing manufacturing of medical devices by designing, documenting, and improving manufacturing processes and operations that ensure product safety, quality, and performance.
- Lead process qualification, verification, and validation activities to support manufacturing operations and regulatory compliance.
- Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost.
- Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements.
- Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
- Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting.
- Participate in risk management and design control activities, including FMEA and design reviews.
- Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance.
- Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation.
- Evaluate and implement process or product alternatives to optimize manufacturing performance.
- Provide technical guidance and training to operators and technicians.
- Collaborate with suppliers and external partners to support equipment, process, and product initiatives.
- Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
