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2 дня назад

Principal Reliability Engineer (Medical Devices)

132 000 - 198 000$
Формат работы
onsite
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
Principal Reliability Engineer (Medical Devices): Providing technical leadership for post-market quality, risk management, and reliability across a cardiac surgery product portfolio with an accent on health risk assessments, surveillance data, and failure analysis. Focus on leading root-cause investigations, evaluating design and risk impacts, and implementing corrective actions that protect patients and sustain product performance.

Location: Mounds View, Minnesota, United States; onsite at least 4 days per week. Travel is expected to be less than 10%. U.S. work authorization sponsorship is available for Principal-level roles and above.

Salary: $132,000–$198,000 USD base salary, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops medical technologies across more than 150 countries to improve patient health and deliver surgical and cardiac care solutions.

What you will do

  • Lead health risk assessments and support post-market risk assessments, hazard analyses, and field corrective action decisions.
  • Monitor product performance, analyze reliability data, and identify trends and quality signals from the field.
  • Lead product failure, complaint, and root-cause investigations.
  • Review and approve FMEAs, test method validations, and verification and validation reports under medical device design controls.
  • Partner with design, manufacturing, quality, and supplier teams on corrective actions and reliability improvements.
  • Provide technical support to customers and field personnel while mentoring junior engineers.

Requirements

  • Bachelor’s degree in science, technology, engineering, mathematics, or a related technical discipline with at least 7 years of relevant experience; or a master’s degree with 5 years; or a PhD with 3 years.
  • For degrees earned outside the United States, the degree must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
  • Experience with risk management, post-market surveillance, reliability engineering, failure analysis, and design controls.
  • Ability to lead complex technical investigations and communicate findings clearly to technical and non-technical audiences.
  • Ability to work onsite in Mounds View at least 4 days per week.

Nice to have

  • Medical device industry experience in product development, operations, or quality.
  • Expertise in risk management according to ISO 14971.
  • Experience with statistical data analysis and complaint trending.

Culture & Benefits

  • Purpose-driven work focused on improving healthcare and patient outcomes.
  • Health, dental, and vision insurance, health savings and flexible spending accounts, and life insurance.
  • Short- and long-term disability coverage, paid time off, and paid holidays.
  • 401(k) plan with employer contribution and match, incentive plans, and employee stock purchase plan.
  • Tuition assistance, employee assistance resources, and a global well-being program.

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