Senior Staff R&D Engineer - Systems

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Job description

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Senior Staff R&D Engineer. In this role, you will provide system-level technical leadership throughout the lifecycle of medical devices, with a focus on commercialization and sustaining engineering, investigate complex product issues, and partner across engineering, quality, manufacturing, regulatory, service, and operations functions to help ensure products remain safe, reliable, compliant, and available to customers.

This role offers a unique opportunity to support a newly integrated business as it advances toward commercialization.

What You Will Do

• 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 product 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 You Will Need

Required Qualifications

• Bachelor’s degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or 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.

Preferred Qualifications

• Minimum 5 years of experience supporting medical devices in a post-commercialization environment.
• Strong mechanical engineering foundation with 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.

US20: $123,100 - $205,200 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.