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7 дней назад

Principal Biomedical Engineer (CGM)

153 000 - 261 000$
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 Biomedical Engineer (CGM): Leading the design, development, and commercialization of continuous glucose monitoring sensors, wearable adhesive patch systems, and related manufacturing processes with an accent on product performance, reliability, manufacturability, and medical-device quality. Focus on transferring complex products from concept through design verification, validation, and high-volume manufacturing, solving technical and root-cause problems, and guiding cross-functional engineering teams.

Location: On-site in Northridge, California, United States

Salary: $153,000–$261,000 USD annually for U.S. locations, including California.

Company

hirify.global develops insulin delivery and continuous glucose monitoring technologies for people living with diabetes.

What you will do

  • Lead the design, development, optimization, and commercialization of CGM sensor components and wearable adhesive patch systems.
  • Translate Voice of Customer feedback and product needs into technical requirements and engineering solutions.
  • Drive product and process development from concept through design verification, validation, and commercial manufacturing transfer.
  • Apply DRM, DFSS, and DFM/A principles; conduct engineering studies, troubleshoot issues, and identify root causes.
  • Collaborate with suppliers, manufacturing partners, and cross-functional teams on materials, components, tooling, equipment, process optimization, and technical challenges.
  • Lead design reviews and project coordination, prepare technical reports, mentor junior engineers, and support biomedical equipment safety, maintenance, regulatory compliance, enzyme research, compound screening, and enzyme assays.

Requirements

  • Bachelor’s degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of relevant experience.
  • Experience in medical device product development and transferring complex products into validated, high-volume manufacturing environments.
  • Strong technical problem-solving, cross-functional leadership, and project coordination skills.
  • Ability to use CAD, GD&T, tolerance analysis, and engineering methods for product and process design.
  • Ability to design and execute engineering studies, support research and preclinical investigations, and communicate technical findings.
  • Ability to independently perform the physical and communication requirements of an office-based role, with reasonable accommodations available where applicable.

Nice to have

  • Experience developing CGMs, insulin pump adhesives, or wearable skin-contact medical devices within design controls and Quality Management systems.
  • Familiarity with ISO 10993 and ISO 13485, DMAIC, root-cause analysis, hypothesis-driven experimentation, and structured failure analysis.
  • Degree in Mechanical Engineering, Biomedical Engineering, or Materials Science; medical device experience.
  • Technical leadership experience, including managing complex projects, influencing stakeholders, and mentoring engineers.
  • Expertise with Minitab, JMP, MATLAB, tolerance loop analysis, process capability, and advanced ANOVA testing.
  • DMAIC or equivalent scientific-method certification, Six Sigma or DRM Green Belt, precision web conversion, multi-layer roll-to-roll manufacturing, process and test method development and validation, and a hands-on approach.

Culture & Benefits

  • Full-time employee position with competitive compensation and flexible benefits.
  • Benefits may include health, dental, and vision insurance; HSA and FSA access; life and disability insurance; paid time off and holidays; and a 401(k) with company match.
  • Additional programs include an Employee Stock Purchase Plan, Employee Assistance Program, and potential retirement and capital accumulation plans subject to eligibility.
  • Regular employees working at least 20 hours per week are generally eligible for the benefits package; some benefits may not apply to temporary staff or Puerto Rico employees.

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