Senior Manufacturing Engineer

What You Will Do:

• Design, develop, document, and continuously improve manufacturing processes and operations that ensure the safety, quality, and performance of medical devices.
• Design, procure, and oversee fabrication of tooling, fixtures, and manufacturing equipment in compliance with applicable safety requirements.
• Lead equipment and process qualification, verification, and validation activities for medical device manufacturing.
• Troubleshoot and resolve manufacturing issues related to safety, quality, delivery, productivity, and cost.
• Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
• Support new product development and product sustaining efforts through technology development, process studies, specification development, process improvements, and technical reporting.
• Participate in design control activities including risk assessments (FMEA), design reviews, and change management initiatives.
• Collaborate with operators, technicians, supervisors, engineers, and cross-functional teams to improve manufacturing performance and resolve production challenges.
• Develop, validate, and implement manufacturing equipment and processes while evaluating opportunities for continuous improvement.
• Support production goals through project planning, scheduling, execution, and documentation.
• Train and provide technical guidance to operators and technicians.
• Coordinate with suppliers and external partners to support process and product improvement initiatives.
• Analyze statistical data to identify trends, improve processes, and support business decisions.
• Demonstrate a commitment to patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.

What You Need:

Required Qualifications

• Bachelor's degree in Mechanical Engineering.
• 2+ years of engineering experience in a manufacturing environment.
• Experience designing and developing tooling and fixtures for manufacturing applications.
• Experience creating, reading, and interpreting engineering drawings using SolidWorks or other engineering design software.
• Ability to perform statistical, geometric, and mathematical analyses to solve technical problems.
• Experience supporting equipment and process validation activities.
• Strong troubleshooting and root cause analysis skills in a manufacturing environment.
• Strong collaboration and communication skills with the ability to work effectively in a team environment.

Preferred Qualifications

• Experience in a regulated industry such as medical device manufacturing.
• Proficiency with Minitab or similar statistical analysis software.Knowledge of Controls Engineering, PLCs, HMIs, sensors
• Experience with Six Sigma, process improvement, and manufacturing optimization initiatives.
• Experience sourcing and managing suppliers, components, and external service providers.
• Experience supporting new product introduction and manufacturing scale-up activities.