Senior Staff R&D Engineer - Systems
Stryker
Summary
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.
Job description
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.
Requirements
- 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.
- 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.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.