4 дня назад
Manufacturing Engineer (Onsite - Acton, MA)
76 400 - 114 575$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manufacturing Engineer (Onsite - Acton, MA) (Medical Device Manufacturing): Improving manufacturing processes and supporting Class II medical device production with an accent on cGMP compliance, FDA guidelines, validation, and engineering change control. Focus on designing manufacturing fixtures, coordinating qualification activities, and managing projects from concept through implementation.
Location: Onsite in Acton, Massachusetts, United States; approximately 33% overnight travel may be required.
Annual base salary: $76,400–$114,575, plus potential incentive compensation.
Company
is a medical device company developing the Omnipod insulin management platform and other drug-delivery technologies.
What you will do
- Plan and adapt manufacturing methods to improve process effectiveness at internal and third-party manufacturing sites.
- Drive product and process improvements through the CAPA system.
- Generate validation and qualification protocols, coordinate execution, and prepare final reports.
- Author and implement Engineering Change Orders.
- Design and coordinate construction of manufacturing fixtures.
- Manage projects from concept and specification through installation, training, qualification, manufacturing implementation, and ongoing support.
Requirements
- Bachelor of Science in an engineering discipline or an equivalent combination of education and experience.
- 3–5 years of experience in a manufacturing environment.
- Ability to maintain a cGMP-compliant environment and operate within FDA guidelines for Class II medical device manufacturing.
- Strong verbal and written communication, prioritization, record-keeping, and teamwork skills.
- Strong computer skills, including Microsoft Office, Microsoft Project, and Statgraphics.
- Ability to work onsite in Acton, Massachusetts.
Nice to have
- Medical device industry experience.
- Knowledge of injection molding, metal stamping/forming, PCB manufacturing, assembly, decorating, extrusion, or ultrasonic welding.
- CAD experience with ProEngineer or SolidWorks.
Culture & Benefits
- Medical, dental, and vision insurance.
- 401(k) plan with company match.
- Paid time off and employee wellness programs.
- Performance-driven environment focused on customer expectations and shared values.
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