Senior Staff R&D Engineer - Systems
$123.1k - $205.2kStryker
Senior Staff R&D Engineer to lead system-level technical activities for commercial medical devices at Stryker's Amplitude Vascular Systems team in Waltham, Massachusetts. Responsibilities include design changes, reliability assessments, product issue investigation, and cross-functional collaboration to ensure device safety and compliance throughout the product lifecycle.
Responsibilities
- Lead system-level engineering activities for commercial medical devices including design changes and lifecycle management
- Conduct reliability assessments and analyze product performance, failure modes, and improvement opportunities
- Investigate product performance issues using field data to identify root causes and solutions
- Define and maintain system requirements, architectures, interfaces, and technical documentation
- Lead risk management, system integration testing, and mentor junior engineers on systems engineering best practices
Requirements
- Bachelor's degree in Systems Engineering, Biomedical, Mechanical, Electrical, or Software Engineering
- Minimum 6 years of engineering experience in a regulated industry
- Experience supporting product development, system integration, design changes, or lifecycle activities
- Post-commercialization medical device experience preferred (5+ years)
- Strong mechanical engineering foundation with multidisciplinary systems exposure
- Knowledge of ISO 13485, ISO 14971, and IEC 60601-1 standards
- Reliability engineering and structured problem-solving methodologies experience
Compensation: $123,100 - $205,200 USD Annual
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