Senior Systems Engineer, Medical Devices — R&D & Lifecycle

Stryker; Waltham (MA); On-site; USD 123,000 - 205,000; Full time

Job summary

Stryker in Waltham, MA, is seeking a Senior Staff R&D Engineer to provide system-level technical leadership throughout the lifecycle of medical devices, with focus on commercialization and sustaining engineering. You will partner across engineering, quality, manufacturing, regulatory, service, and operations to ensure products remain safe, reliable, compliant, and available.

The role offers a unique opportunity as the business integrates toward commercialization, with responsibilities spanning

Qualifications

• Bachelor’s degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or related field.
• Minimum 6 years of engineering experience in a regulated industry.
• Experience supporting product development, system integration, design changes, or product lifecycle activities.

Responsibilities

• Lead system-level engineering activities for commercial medical devices, including design changes and lifecycle management.
• Lead reliability assessments and analysis to improve product reliability and longevity.
• Investigate product performance issues using data to identify root causes and improvements.
• Define, maintain, and refine system requirements, architectures, interfaces, and documentation.
• Allocate and decompose system requirements across electrical, mechanical, and software subsystems.
• Lead risk management activities including hazard identification, risk analysis, and mitigation planning.
• Lead and support system integration, reliability, regression, and verification testing for product changes.
• Drive resolution of complex design, manufacturing, and service-related technical issues.

Skills

Systems engineering

Regulated industry experience

Cross-functional collaboration

Education

Bachelor’s degree in Systems Engineering

Tools

Jama

SysML

MBSE

Job description

Stryker in Waltham, MA, is seeking a Senior Staff R&D Engineer to provide system-level technical leadership throughout the lifecycle of medical devices, with focus on commercialization and sustaining engineering. You will partner across engineering, quality, manufacturing, regulatory, service, and operations to ensure products remain safe, reliable, compliant, and available.

The role offers a unique opportunity as the business integrates toward commercialization, with responsibilities spanning