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Job Role: Manufacturing Engineer
Location: Foxborough MA
Contract: W2
Responsibilities: - Design processes specify equipment develop work instructions conduct validation (IQ OQ PQ) and train production staff.
- Create validate and deploy automated semiautomated 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 leadtime 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.
Required Skills/Abilities: - Proficiency in designing and fabricating electromechanical components and assemblies.
- Experience with SolidWorks
- Experience with FDA GMP QSR and ISO 13485 guidelines.
Education and Experience: - Bachelors 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).