Senior Product Engineer
Stryker
Summary
Join Stryker's Sustainability Solutions team and contribute to the development, improvement, and ongoing support of medical devices. In this role, you will work across product design, engineering, quality, and manufacturing to address technical challenges, support product changes, and maintain compliance with regulatory requirements. This opportunity combines hands-on engineering, problem-solving, and cross-functional collaboration throughout the product lifecycle.
Job description
What You Will Do
- Lead engineering activities supporting new and existing medical devices, including product improvements, design changes, and line extensions.
- Manage design control activities, risk assessments, and regulatory documentation to maintain compliance with FDA requirements.
- Investigate product and packaging failures, identify root causes, and implement corrective actions to address quality issues.
- Support customer complaint investigations by partnering with Quality and Manufacturing teams to evaluate product performance and resolve technical issues.
- Plan and execute engineering research, product design, development, verification, and validation activities.
- Collaborate with Research and Development, Quality, Regulatory Affairs, Manufacturing, Marketing, and external suppliers to support product development and manufacturing improvements.
- Apply statistical analysis and engineering testing methods to evaluate product performance, analyze results, and support technical decisions.
- Drive continuous improvement initiatives by identifying opportunities to improve product quality, manufacturing processes, customer experience, and operational efficiency.
What You Will Need
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
- Minimum 2 years of engineering experience in a regulated industry.
- Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives.
Preferred Qualifications
- Engineering experience within the medical device industry.
- Experience with engineering design, product troubleshooting, or process improvement activities.
- Experience with technical documentation, engineering testing, or product verification and validation.
- Experience with FDA medical device regulations, design controls, risk management, or regulatory submission support.
- Experience using SolidWorks or similar computer-aided design software.
Requirements
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field
- Minimum 2 years of engineering experience in a regulated industry
- Experience supporting product investigations, design changes, validation activities, or quality improvement initiatives
- Engineering experience within the medical device industry
- Experience with engineering design, product troubleshooting, or process improvement activities
- Experience with technical documentation, engineering testing, or product verification and validation
- Experience with FDA medical device regulations, design controls, risk management, or regulatory submission support
- Experience using SolidWorks or similar computer-aided design software
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.