MARVEL Infotech Inc.
Overview
Senior Manufacturing Engineer – Medical Device (Hands-On Role) We’re 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. Needs to have 9+ years of medical device experience
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
Bachelor’s 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
Board-Level Troubleshooting
Board-Level Failure Analysis
Electronic Board Fault Localization
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Medical Equipment Manufacturing
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Senior Manufacturing Engineer – Medical Device (Hands-On Role) We’re 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. Needs to have 9+ years of medical device experience
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
Bachelor’s 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
Board-Level Troubleshooting
Board-Level Failure Analysis
Electronic Board Fault Localization
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Manufacturing
Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr