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Stark Associates LLC is Hiring a Manufacturing Engineer Near Foxborough, MA
Job Description
- Design processes, specify equipment, develop work instructions, conduct validation (IQ, OQ, PQ), and train production staff.
- Create, validate, and deploy automated, semi-automated, and manual assembly and test equipment and tooling for disposable product manufacturing, ensuring proper documentation, calibration, and preventative maintenance control.
- Engage in FMEA activities to identify and rectify process deficiencies effectively.
- Collaborate with Design Engineers and Quality Assurance to ensure products are designed for ease of manufacturing and compliance with performance, cost, and quality standards.
- Coordinate with Quality Assurance and Research and Development to uphold an approved internal Quality System meeting FDA QSR and ISO 13485 requirements.
- Aid in pilot production of various products, establishing lean manufacturing cells to enhance throughput and quality.
- Support product production, including ensuring proper operator training, adherence to production schedules, and accuracy of production documentation. Collaborate with production staff to pinpoint areas for enhancement.
- Continuously enhance safety, quality, lead-time, productivity, and cost of existing manufacturing processes.
- Identify root causes of manufacturing process nonconformities using NCMR and CAPA and enact necessary measures to rectify and prevent recurrence.
- Proficiency in designing and fabricating electromechanical components and assemblies.
- Experience with SolidWorks
- Experience with FDA GMP, QSR, and ISO 13485 guidelines.
- Bachelor's Degree in Mechanical Engineering, Mechanical Engineering Technology, Manufacturing Engineering, or a related field.
- 5 to 8 years of experience in medical device manufacturing.
- Experience in a medical device environment (ISO 13485 and FDA QSR).
Job Summary
Full Time
$102k-120k (estimate)
06/26/2024
07/12/2024
The following is the career advancement route for Manufacturing Engineer positions, which can be used as a reference in future career path planning. As a Manufacturing Engineer, it can be promoted into senior positions as an Industrial Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing Engineer. You can explore the career advancement for a Manufacturing Engineer below and select your interested title to get hiring information.
