Transcend Staffing Solutions LLC. a 100% Women Owned Minority Staffing Firm!
Senior Manufacturing Engineer
Transcend Staffing Solutions LLC. a 100% Women Owned Minority Staffing Firm!, Burlington, Massachusetts, us, 01805
Direct message the job poster from Transcend Staffing Solutions LLC. a 100% Women Owned Minority Staffing Firm!
Position: Senior Manufacturing Engineer – Needs to have 7+ years of medical device experience Location: Burlington, MA area – 5 days onsite, no remote
Duration: Full-Time/Direct
Domain: Medical Device
Job Description 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.
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.
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Position: Senior Manufacturing Engineer – Needs to have 7+ years of medical device experience Location: Burlington, MA area – 5 days onsite, no remote
Duration: Full-Time/Direct
Domain: Medical Device
Job Description 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.
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.
#J-18808-Ljbffr