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2 дня назад

Senior Design Engineer (Medical Devices)

101 000 - 152 000$
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
Senior Design Engineer (Medical Devices): Leading the design and development of new medical devices from ideation through 510(k) application, design transfer, and product launch with an accent on design specifications, prototyping, validation, and manufacturing collaboration. Focus on coordinating multidisciplinary teams, managing design controls and risk assessments, solving production and validation issues, and launching Class II devices.

Location: Hybrid, Northfield, Illinois, United States. Travel up to 10% of the time for domestic and international business purposes.

Salary: $101,000–$152,000 annually, plus bonus and/or incentive eligibility.

Company

hirify.global is a growing worldwide organization developing and manufacturing medical products and devices.

What you will do

  • Lead multidisciplinary product development teams researching, designing, and developing new products and technologies.
  • Coordinate product development from ideation through 510(k) application, design transfer, implementation, and product launch.
  • Develop design specifications, manage project timelines, and align product development with divisional strategies.
  • Collaborate with customers, quality, regulatory, legal, manufacturers, and product divisions to ensure successful product launches.
  • Coordinate design and laboratory teams to verify and validate design inputs, prototypes, drawings, and specifications.
  • Review existing products, troubleshoot manufacturing issues, support intellectual property initiatives, and identify improvement opportunities.

Requirements

  • Bachelor’s degree in mechanical, biomedical, electrical, or software engineering.
  • At least 7 years of product design experience; 10 years preferred.
  • Experience with SolidWorks or comparable 3D modeling software and prototype fabrication.
  • Experience with medical device requirements, Class I–II devices, design controls, risk assessments, and the 510(k) process.
  • Experience leading multidisciplinary teams, managing projects, and coordinating design transfer to manufacturing.
  • Ability to travel up to 10% domestically and internationally.

Nice to have

  • Certified SolidWorks Professional certification.
  • Experience with polymers, textiles, medical equipment, injection molding, and other manufacturing processes.
  • Experience designing and launching Class II medical devices.
  • Microsoft Project experience and at least one recognized patent.

Culture & Benefits

  • Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees.
  • Continuing education and training opportunities.
  • Diversity, inclusion, belonging, and career development initiatives.
  • Employee Assistance Program, Employee Resource Groups, and Employee Service Corps access for eligible employees.

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