Staff R&D Engineer

Stryker•Waltham, MA
•$107,200 - $178,600•Onsite

About The Position

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff R&D Engineer - Systems Engineering. This onsite role supports development of complex medical devices from concept through commercialization, working across software, electrical, and mechanical systems. The engineer translates stakeholder and clinical needs into system requirements and guides system architecture, interface management, risk management, integration, verification, and validation across multidisciplinary engineering teams.

Requirements

  • Bachelor of Science degree in Software Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Biomedical Engineering, or a related engineering discipline.
  • Minimum 4 years of engineering work experience.

Nice To Haves

  • Experience developing and optimizing system requirements, system designs, and verification strategies.
  • Experience using requirements management software, preferably Jama.
  • Experience with Systems Modeling Language (SysML) and Model-Based Systems Engineering (MBSE) methods and tools.
  • Knowledge of ISO 13485 and ISO 14971 requirements and their application to medical device development.
  • Experience working with software and/or electrical systems.
  • Familiarity with C++, MATLAB, or scripting languages.

Responsibilities

  • Translate user, stakeholder, and clinical needs into clear system-level requirements and design inputs for complex medical devices.
  • Develop and refine system architectures, interfaces, requirements, and verification strategies across mechanical, electrical, and software disciplines.
  • Allocate and decompose system requirements using modeling, simulation, engineering budgets, and mathematical techniques.
  • Support concept-phase engineering activities, including trade studies, sensitivity analyses, optimization studies, performance assessments, and design assessments.
  • Drive system integration, verification, and validation activities and resolve complex product design issues using engineering analysis and technical judgment.
  • Contribute to product risk management activities and apply applicable medical device standards, design controls, and risk management practices throughout development.
  • Create and refine engineering documentation, including Design History File documentation, and mentor team members on development procedures and applicable industry standards.
  • Collaborate with clinical, quality, regulatory, manufacturing, and engineering partners, including supporting Voice of Customer activities with clinicians, to identify technical risks and advance projects through development and launch.
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