1 день назад
Principal System Test Engineer (Hybrid Boston)
90 100 - 153 300$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal System Test Engineer (Medical Devices): Leading system-level verification and validation for complex medical device, hardware, software, and integrated system products with an accent on risk-based test methods, requirements traceability, and regulated product development. Focus on designing V&V strategies, automating system integration testing, analyzing statistical test data, and resolving technical risks across engineering, quality, and product teams.
Location: Hybrid in Boston, MA, US
Salary: $90,100–$153,300 annually, plus potential discretionary annual bonus and long-term incentive eligibility.
Company
develops medical technology products and services focused on safe, effective, and high-quality healthcare solutions.
What you will do
- Lead system-level verification and validation for complex medical device, hardware, software, interface, and integrated system products.
- Develop and approve V&V strategies, requirements, test plans, protocols, procedures, and reports.
- Define risk-based, statistical, and design-of-experiments test methods.
- Provide technical leadership for system integration, test automation, fixtures, tools, and test equipment.
- Review V&V evidence, resolve technical issues, and support design reviews and cross-functional decisions.
- Improve requirements and test management practices while mentoring technical contributors.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or a related technical field.
- Strong knowledge of regulated product development, including FDA design controls, ISO quality systems, CE Marking, and V&V expectations.
- Deep experience with system-level V&V, requirements management, traceability, risk management, test coverage, and objective evidence.
- Hands-on experience with system integration, test method validation, automated testing, engineering tools, fixtures, and test equipment.
- Experience with statistical analysis, design of experiments, and scripting or analytical tools such as Python, MATLAB, R, or LabVIEW.
- Strong technical judgment, communication, collaboration, mentoring, and problem-solving skills.
Nice to have
- Reliability engineering experience with RGT, RBD, Weibull analysis, ALT, HALT, or HASS.
- Experience developing medical devices, software, hardware, or complex electromechanical systems.
- Proficiency with requirements and test management tools such as DOORS, Polarion, or Cognition Cockpit.
Culture & Benefits
- Hybrid work environment in Boston.
- 401(k) with up to a 6% employer match and no vesting period.
- Employee stock purchase plan and potential long-term incentive participation.
- Flexible time off for salaried employees, paid sick time, holidays, and parental leave.
- Disability insurance, tuition reimbursement, and health and welfare benefits.
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