Senior Product Engineer

Stryker; Tempe (AZ); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker's Sustainability Solutions team in Tempe, AZ, is seeking a Senior Engineer for Product Engineering to drive design changes, verify and validate devices, and support regulatory compliance across the product lifecycle.

You will collaborate with design, quality, regulatory, and manufacturing teams to address technical challenges, investigate issues, and enable product improvements while leveraging statistical methods and testing. Hybrid work requires onsite several days a week.

Qualifications

• Bachelor's degree in an engineering discipline required.
• Minimum 2 years of engineering experience in a regulated industry.
• Experience with product investigations, design changes, validation activities, or quality improvement initiatives.

Responsibilities

• Lead engineering activities for new and existing medical devices, including product improvements and line extensions.
• Manage design control activities, risk assessments, and regulatory documentation to maintain FDA compliance.
• Investigate product and packaging failures, identify root causes, and implement corrective actions.
• Support customer complaint investigations by partnering with Quality and Manufacturing to resolve issues.
• Plan and execute engineering research, design, development, verification, and validation activities.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Marketing, and suppliers to support development and manufacturing improvements.
• Apply statistical analysis and testing methods to evaluate performance and support decisions.
• Drive continuous improvement to enhance product quality and manufacturing efficiency.

Skills

Regulated industry experience

Design controls

Quality improvement

Education

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field

Tools

SolidWorks

Job description

Senior Engineer - Product Engineering

Tempe, AZ

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.

Work Flexibility:
Hybrid: candidates must reside within commuting distance of Tempe, AZ and be able to work onsite several days per week.

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.

$77,700 - $129,500 USD Annual