Staff Automation Engineer NPI (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →