MARVEL Infotech Inc.
Senior Manufacturing Engineer (Burlington)
MARVEL Infotech Inc., Burlington, Massachusetts, United States, 01805
Senior Manufacturing Engineer
Location: Burlington, MA
Domain:
Medical Device manufacturing.
Needs to have 9+ years of medical device experience
Senior Manufacturing Engineer
Medical Device (Hands-On Role) Were seeking a hands-on Senior Manufacturing Engineer to support daily production and process improvement for medical devices, ensuring compliance with FDA and ISO 13485 standards.
Responsibilities: Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ). Work directly on the production floor to troubleshoot and resolve process and quality issues. Lead root cause investigations and implement corrective/preventive actions. Partner with Quality, R&D, and Operations to support design transfer and new product builds. Maintain accurate documentation, including DHRs, BOMs, and process instructions.
Qualifications: Bachelors degree in Engineering and 7+ years of medical device manufacturing experience. Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements. Proven ability to work cross-functionally and solve complex process problems. Hands-on NPI (New Product Introduction) experience is a major plus.
Skills:
ISO 13485: Medical Device: QMS: DHR: BOMs: Solidworks: Cost Out: Circuit Board Fault Diagnosis PCB Fault Detection: Board-Level Troubleshooting: Board-Level Failure Analysis: Electronic Board Fault Localization: Circuit Board Debugging:
Domain:
Medical Device manufacturing.
Needs to have 9+ years of medical device experience
Senior Manufacturing Engineer
Medical Device (Hands-On Role) Were seeking a hands-on Senior Manufacturing Engineer to support daily production and process improvement for medical devices, ensuring compliance with FDA and ISO 13485 standards.
Responsibilities: Develop, validate, and improve manufacturing processes and equipment (IQ/OQ/PQ). Work directly on the production floor to troubleshoot and resolve process and quality issues. Lead root cause investigations and implement corrective/preventive actions. Partner with Quality, R&D, and Operations to support design transfer and new product builds. Maintain accurate documentation, including DHRs, BOMs, and process instructions.
Qualifications: Bachelors degree in Engineering and 7+ years of medical device manufacturing experience. Strong understanding of GMP, FDA 21 CFR 820, and ISO 13485 requirements. Proven ability to work cross-functionally and solve complex process problems. Hands-on NPI (New Product Introduction) experience is a major plus.
Skills:
ISO 13485: Medical Device: QMS: DHR: BOMs: Solidworks: Cost Out: Circuit Board Fault Diagnosis PCB Fault Detection: Board-Level Troubleshooting: Board-Level Failure Analysis: Electronic Board Fault Localization: Circuit Board Debugging: