10 дней назад
Senior Manufacturing Engineer (Onsite - Acton)
118 700 - 178 025$
Мэтч & Сопровод
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Описание вакансии
Текст:
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
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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