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51 минуту назад

Sr Engineer (Medical Device Reliability)

85 000 - 95 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr Engineer (Medical Device Reliability) (Medical Devices): Planning, designing, executing, and analyzing reliability tests for new medical device products and product changes with an accent on electromechanical systems, regulated documentation, and reliability data analysis. Focus on developing QALT and life-testing protocols, fabricating test fixtures, investigating field failures, and demonstrating product reliability to quality and regulatory standards.

Location: Hybrid role with three days per week in Warrendale, Pennsylvania, United States

Salary: $85,000–$95,000 per year

Company

hirify.global is a medical technology company developing and supporting healthcare products in a regulated environment.

What you will do

  • Plan, design, execute, document, and analyze reliability tests for new products and product changes.
  • Develop and execute test protocols, including Quantitative Accelerated Life Testing and Reliability Life Testing.
  • Design, fabricate, maintain, and qualify reliability test fixtures and equipment.
  • Analyze test results, defects, field failures, and reliability metrics using structured data and test databases.
  • Support root cause analysis, troubleshooting documentation, technical reviews, and compliance documentation.
  • Collaborate with Hardware, Sustaining, Systems, Quality, Regulatory, and R&D teams.

Requirements

  • Bachelor’s degree in Engineering or equivalent experience.
  • At least three years of hands-on experience as a reliability engineer or systems test engineer on product development teams.
  • Experience with electromechanical assemblies, complex mechanisms, reliability testing, test design, and engineering documentation.
  • Experience using PLM systems to manage documentation revisions in accordance with FDA requirements.
  • Strong data analysis, troubleshooting, test protocol development, technical writing, and presentation skills.
  • Must be authorized to work for any employer in the United States; visa sponsorship is not available now or in the future. Effective English communication is required.

Nice to have

  • Weibull and reliability statistics, accelerated life testing, DFMEA, ISO 14971, and medical device design controls.
  • Experience with Minitab, JMP, ReliaSoft Weibull++, MATLAB, Python, Excel, Access, Windchill, or requirements management tools.
  • SQL, project planning, mentoring junior engineers and technicians, and experience justifying reliability strategies to management and regulators.

Culture & Benefits

  • Collaborative work across Hardware, Systems, Quality, Regulatory, and R&D functions.
  • Medical, prescription drug, dental, and vision coverage.
  • 401(k) plan with company contributions, life insurance, disability coverage, and wellness programs.
  • Paid vacation, holidays, and personal days, plus an employee assistance program.
  • Work is performed in a hands-on development laboratory within a regulated quality and safety environment.

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