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обновлено 8 дней назад

Senior Mechanical Engineer - Medical Devices

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
Senior Mechanical Engineer - Medical Devices (MedTech): Designing and developing medical device components, mechanisms, and assemblies from concept through commercialization with an accent on manufacturability, verification, risk management, and regulatory compliance. Focus on leading cross-functional design efforts, creating robust mechanical systems, and mentoring junior engineers across safety-critical healthcare programs.

Location: Hybrid remote in Bedford, New Hampshire, with on-site work at the Bedford facility one day per month on average.

Company

Develops medical technologies with clients, including ingestible sensing, artificial-womb technology, surgical robotics, and implanted cardiac assist devices.

What you will do

  • Lead mechanical design and development of medical device components, mechanisms, and assemblies.
  • Own product development from requirements and concept through design, prototyping, verification, commercialization, and manufacturing transfer.
  • Design robust, manufacturable solutions using appropriate materials, processes, tolerances, and cost considerations.
  • Conduct risk management activities, design reviews, and FMEA to support compliance with applicable regulations and standards.
  • Create and maintain CAD models, drawings, and Design History Files.
  • Collaborate with electrical, software, quality, manufacturing, and regulatory teams while mentoring junior engineers.

Requirements

  • B.S. or M.S. in Mechanical Engineering or a related field.
  • 7–10 years of product development experience, including at least 5 years in medical devices or other regulated industries.
  • Demonstrated experience bringing products from concept to market.
  • Proficiency in 3D CAD, such as SolidWorks, and PDM systems.
  • Strong knowledge of DFM/DFA, GD&T, and mechanical system design.
  • Experience with mechanisms and mechanical analysis.
  • Familiarity with verification testing, reliability engineering, and human factors considerations.
  • Excellent problem-solving, communication, and technical leadership skills.
  • Ability to work independently and lead cross-functional design efforts.

Nice to have

  • Class II or Class III medical device experience; standout mechanical talent from aerospace, defense, robotics, or other safety-critical compliance sectors is also considered.
  • Experience with fluidics, micro-mechanisms, or disposable device design.
  • Hands-on prototyping and test fixture development.
  • Exposure to project management tools and agile development methodologies.

Culture & Benefits

  • Flexible hybrid working environment with approximately one day per month on site.
  • Collaborative engineering culture.
  • Opportunity to work across ambitious healthcare technology development programs.

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