Senior Manufacturing Engineer
Stryker
Summary
At Stryker Robotics, manufacturing engineering plays a critical role in delivering reliable, high-quality robotic systems that support healthcare providers around the world. In this role, you will partner across engineering, quality, operations, and supply chain teams to improve manufacturing performance, support new product introductions, and drive operational excellence on the production floor.
Job description
This position provides hands-on manufacturing engineering support for the assembly of complex electromechanical systems while leveraging data, process improvements, and problem-solving methodologies to enhance quality, efficiency, throughput, and cost performance.
What You Will Do
- Provide direct manufacturing engineering support to production operations by troubleshooting process issues, leading root cause investigations, and driving timely resolution of manufacturing challenges.
- Execute manufacturing process validation and equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in compliance with quality and regulatory requirements.
- Analyze manufacturing data using statistical tools to improve process capability, support measurement system analysis, and identify opportunities to improve quality, throughput, ergonomics, and cost.
- Collaborate with Quality, Research & Development, Advanced Operations, and Supply Chain teams to support design for manufacturability, new product introductions, production readiness activities, and continuous improvement initiatives.
- Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, process failure mode and effects analyses, control plans, and visual aids in accordance with quality management system requirements.
What You Will Need
Required:
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Robotics Engineering, or a related engineering discipline.
- Minimum 2 years of manufacturing engineering experience.
- Experience supporting complex mechanical and/or electromechanical assemblies.
- Experience working within a regulated manufacturing environment.
Preferred:
- Experience in medical device, robotics, high-tech assembly, or other regulated manufacturing industries.
- Experience supporting nonconformance investigations, corrective and preventive actions, process validation, and continuous improvement initiatives.
- Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and risk-based validation methodologies.
- Proficiency with engineering and statistical analysis tools such as SolidWorks, Minitab, and Geometric Dimensioning & Tolerancing (GD&T).
Requirements
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Electrical Engineering, Manufacturing Engineering, Robotics Engineering, or a related engineering discipline.
- Minimum 2 years of manufacturing engineering experience.
- Experience supporting complex mechanical and/or electromechanical assemblies.
- Experience working within a regulated manufacturing environment.
- Experience in medical device, robotics, high-tech assembly, or other regulated manufacturing industries.
- Experience supporting nonconformance investigations, corrective and preventive actions, process validation, and continuous improvement initiatives.
- Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, and risk-based validation methodologies.
- Proficiency with engineering and statistical analysis tools such as SolidWorks, Minitab, and Geometric Dimensioning & Tolerancing (GD&T).
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.