Develops complex medical devices from concept through commercialization by translating clinical and stakeholder needs into system requirements and architectures. Leads interface management, risk management, integration, verification, and validation across software, electrical, and mechanical disciplines. Supports trade studies, modeling, simulations, design assessments, and product risk activities. Creates design documentation, collaborates with clinical, quality, regulatory, manufacturing, and engineering teams, and mentors team members on development procedures and medical device standards.
Work Flexibility: Onsite
Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham, Massachusetts as a Staff R&D Engineer - Systems Engineering. In this role, you’ll be supporting the development of complex medical devices from concept through commercialization, working across software, electrical, and mechanical systems. You will translate stakeholder and clinical needs into system requirements and guide system architecture, interface management, risk management, integration, verification, and validation across multidisciplinary engineering teams.
What you will do
- 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.
What you will need
Required qualifications
- 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.
Preferred qualifications
- 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.
US20: $107,200 - $178,600 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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