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7 дней назад

Staff Automation Engineer NPI (Medical Devices)

133 400 - 200 075$
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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TL;DR
Staff Automation Engineer NPI (Medical Devices): Developing and scaling manufacturing equipment and automated assembly processes for new product introductions from feasibility and pilot builds through high-volume production with an accent on equipment architecture, validation, and regulated manufacturing. Focus on leading capital equipment programs, integrating robotics and controls, resolving cross-functional technical risks, and ensuring compliant production scale-up across sites and suppliers.

Location: Acton, Massachusetts, United States. Hybrid role based in Acton, with an expectation of working in the office at least four days per week; travel up to 10%, including international travel to equipment vendors and manufacturing sites. Able to work in a Class 8 cleanroom environment as needed.

Annual base salary: $133,400.00–$200,075.00. The role may also be eligible for incentive compensation.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other drug-delivery solutions.

What you will do

  • Lead manufacturing process and equipment development for complex new product introduction programs from feasibility and manual assembly through pilot, automation, and high-volume production.
  • Define scalable assembly strategies and technical roadmaps for manual, semi-automated, and fully automated production.
  • Own major capital equipment projects, including requirements, vendor strategy, design reviews, acceptance, validation, and production handoff.
  • Establish equipment and process architectures, engineering standards, and reusable approaches that improve scalability, reliability, and consistency across sites.
  • Influence product and process design through DFM/DFA and direct resolution of technical risks across equipment, process, controls, quality, and operations.
  • Mentor engineers and provide technical direction on equipment architecture, automation strategy, vendor selection, capital priorities, and manufacturing scale-up.

Requirements

  • Bachelor’s degree in mechanical, industrial, manufacturing, electrical, automation, or a related engineering discipline.
  • 12+ years of relevant experience in manufacturing engineering, equipment engineering, or automation within a regulated industry.
  • Experience leading complex capital equipment programs from requirements through validation and production handoff.
  • Expertise in automated assembly equipment and integration, including robotics, motion control, vision, sensing, PLC/HMI, or manufacturing data systems.
  • Working knowledge of regulated manufacturing requirements, including equipment validation, design controls, risk management, and change control.
  • Ability to meet regulatory, quality, safety, and cybersecurity requirements for equipment and process solutions.

Nice to have

  • Master’s degree in engineering or engineering management.
  • Experience with Class II medical device manufacturing.
  • Experience scaling manufacturing from early feasibility or pilot builds through high-volume automated production.
  • Experience applying DFM/DFA and process capability methods to automated assembly systems.
  • Experience leading technical decisions across multiple functions, suppliers, and manufacturing sites.

Culture & Benefits

  • Hybrid work arrangement with regular office presence in Acton.
  • Medical, dental, and vision insurance.
  • 401(k) with company match.
  • Paid time off and employee wellness programs.
  • Work in a regulated medical device environment focused on manufacturing innovation and global growth.

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