Senior Staff R&D Engineer - Systems

Stryker; Waltham (MA); Presencial; USD 123.000 - 205.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Systems engineering

Regulated industry experience

Cross-functional collaboration

Educación

Bachelor’s degree in Systems Engineering

Herramientas

Jama

SysML

MBSE

Descripción del empleo

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

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