Senior Staff R&D Engineer - Systems

Stryker • Waltham, MA

19h • Onsite

About The Position

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Senior Staff R&D Engineer. This onsite role provides system-level technical leadership throughout the lifecycle of medical devices, with a focus on commercialization and sustaining engineering. The engineer investigates complex product issues and partners across engineering, quality, manufacturing, regulatory, service, and operations to help ensure products remain safe, reliable, compliant, and available to customers. The role supports a newly integrated business as it advances toward commercialization.

Requirements

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

Nice To Haves

• Minimum 5 years of experience supporting medical devices in a post-commercialization environment.
• Strong mechanical engineering foundation and experience working across multidisciplinary systems, including exposure to electrical and/or software components.
• Experience with requirements management tools, including Jama.
• Experience with SysML and model-based systems engineering (MBSE) methodologies and tools.
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, and medical device design control requirements.
• Experience with reliability engineering, fault tree analysis, FMEA, statistical analysis, and structured problem-solving methodologies.

Responsibilities

• Lead system-level engineering activities for commercial medical devices, including design changes, product evaluations, and lifecycle management.
• Lead reliability assessments and analysis to understand product performance, failure modes, and opportunities to improve reliability and longevity.
• Investigate product performance issues using field, service, manufacturing, reliability, and complaint data to identify root causes and improvement opportunities.
• Define, maintain, and refine system requirements, architectures, interfaces, and technical documentation.
• Allocate and decompose system requirements across electrical, mechanical, and software subsystems.
• Lead risk management activities, including hazard identification, risk analysis, mitigation planning, and verification of safety requirements.
• Lead and support system integration, reliability, regression, and verification testing associated with product changes.
• Drive resolution of complex design-, manufacturing-, and service-related technical issues through structured engineering analysis.
• Mentor engineers and provide technical guidance on systems engineering methods, design controls, industry standards, and engineering best practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior