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10 дней назад

Senior Manufacturing Engineer (Onsite - Acton)

118 700 - 178 025$
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

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TL;DR
Senior Manufacturing Engineer (Medical Devices): Leading process improvements, equipment validations, new product introductions, and continuous improvement for highly automated, high-volume manufacturing of electro-mechanical medical devices with an accent on Lean Six Sigma, statistical analysis, automation troubleshooting, and FDA-compliant validation. Focus on solving complex manufacturing problems, managing equipment and process projects, and building reliable production processes in a regulated Class II medical device environment.

Location: Onsite at the Acton, Massachusetts site, United States. Up to 5% international travel may be required, including North America and APAC.

Annual base salary: $118,700–$178,025, plus potential incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod wearable insulin delivery platform and related drug delivery technologies for people with diabetes and other conditions.

What you will do

  • Lead continuous improvement initiatives for highly automated, high-volume manufacturing processes and equipment.
  • Manage new product introductions, equipment installations and upgrades, component introductions, and implementation into production.
  • Drive product and process improvements focused on quality, efficiency, cost, and key performance indicators.
  • Conduct root cause investigations using structured problem-solving methods and standardized tools.
  • Develop and execute IQ, OQ, TMV, CSV, and PQ validation protocols and prepare qualification reports.
  • Collaborate with Maintenance, Equipment Design, Controls, Operations, Quality, and Engineering teams while maintaining accurate GDP-compliant documentation.

Requirements

  • Onsite work at the Acton, Massachusetts facility is required.
  • High school diploma with 10+ years of engineering experience in a highly regulated manufacturing environment; or a B.S. in Mechanical, Industrial, or Electrical Engineering with 5+ years of experience; or an M.S. in Engineering or Engineering Management with 3+ years of experience.
  • Experience with Lean Six Sigma, structured problem solving, statistical process control, design of experiments, and validation techniques.
  • Strong Microsoft Office, Excel, and data analysis skills, with working knowledge of Minitab or JMP.
  • Working knowledge of SolidWorks and engineering drawing interpretation.
  • Ability to troubleshoot semi-automated and fully automated mechanical equipment and manage manufacturing projects.

Nice to have

  • Medical device industry experience.
  • High-volume manufacturing or automation experience.
  • Experience with molded components, stamped metal, and springs.

Culture & Benefits

  • Onsite work in a fast-growing global medical device organization.
  • Medical, dental, and vision insurance.
  • 401(k) with company match.
  • Paid time off and employee wellness programs.
  • Work focused on improving outcomes for people with diabetes.

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