What are the responsibilities and job description for the Lead Manufacturing Engineer position at Invent Staffing?
Role: Manufacturing Engineer Lead
Location: Arlington, TN Onsite
Industry: Medical Devices
Key Responsibilities:
Lead process validation (IQ, OQ, PQ), PFMEA, SPC, and Six Sigma initiatives.
Ensure quality performance of products/processes and support new product introductions.
Develop scalable, high-yield manufacturing processes and robust inspection strategies.
Drive risk management (ISO 14971) and regulatory compliance (FDA 510K, EU MDR, ISO 13485).
Oversee supplier qualification, PPAP approvals, and QMS documentation remediation.
Support CAPA investigations, continuous improvement, and lean manufacturing strategies.
Develop and maintain work instructions, process flows, and equipment validations.
Qualifications & Experience:
10-13 years in medical device manufacturing.
Expertise in CAPA, DOE, SQC, quality planning, and regulatory standards.
Bachelor’s degree in Manufacturing, Industrial Engineering, or related field.
Strong knowledge of FDA regulations, process optimization, and DFMA.
