Intellectt Inc
Medical Devices | Pharma | Bio Technology
Job Title:
Manufacturing Engineer
Location:
GA
Duration:
06+ Months
Position Overview
We are seeking a skilled Manufacturing Engineer with hands‑on experience in the medical device industry to support production, process improvement, and manufacturing efficiency. The ideal candidate will have a strong understanding of GMP, FDA 21 CFR Part 820, and ISO 13485 requirements, along with proven experience in process validation, equipment qualification, and continuous improvement within a regulated environment.
Key Responsibilities
Develop, optimize, and validate manufacturing processes for medical device production.
Support the design transfer of new products from R&D to manufacturing.
Prepare and maintain process documentation, including work instructions, validation protocols/reports, and equipment qualification records.
Collaborate with cross‑functional teams (R&D, Quality, Production, and Supply Chain) to ensure smooth project execution and compliance with regulatory standards.
Identify opportunities for process improvement, cost reduction, and efficiency enhancement through Lean and Six Sigma methodologies.
Troubleshoot process issues and implement corrective and preventive actions (CAPA).
Participate in equipment selection, installation, and maintenance planning.
Ensure manufacturing processes comply with cGMP, FDA, and ISO quality system regulations.
Provide training and technical support to production staff on new or revised processes.
Support internal and external audits and contribute to regulatory compliance activities.
Qualifications
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field.
2–7 years of experience in manufacturing engineering within the medical device or biotech industry.
Strong understanding of FDA, ISO 13485, and GMP standards.
Experience with process validation (IQ/OQ/PQ), equipment qualification, and documentation control.
Proficiency in root cause analysis, FMEA, and CAPA methodologies.
Hands‑on experience with manufacturing equipment, automation, or injection molding is a plus.
Proficient in CAD tools (SolidWorks or similar) and Microsoft Office Suite.
Excellent analytical, problem‑solving, and communication skills.
Preferred Qualifications
Lean Six Sigma Green Belt or equivalent certification.
Experience with cleanroom manufacturing or Class II/III medical devices.
Working knowledge of ERP/MRP systems (SAP, Oracle, etc.).
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Other
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
Referrals increase your chances of interviewing at Intellectt Inc by 2x
Sign in to set job alerts for “Manufacturing Engineer” roles. Lithonia, GA $115,000.00-$130,000.00 3 days ago
Warner Robins, GA $70,000.00-$85,000.00 6 days ago
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Manufacturing Engineer
Location:
GA
Duration:
06+ Months
Position Overview
We are seeking a skilled Manufacturing Engineer with hands‑on experience in the medical device industry to support production, process improvement, and manufacturing efficiency. The ideal candidate will have a strong understanding of GMP, FDA 21 CFR Part 820, and ISO 13485 requirements, along with proven experience in process validation, equipment qualification, and continuous improvement within a regulated environment.
Key Responsibilities
Develop, optimize, and validate manufacturing processes for medical device production.
Support the design transfer of new products from R&D to manufacturing.
Prepare and maintain process documentation, including work instructions, validation protocols/reports, and equipment qualification records.
Collaborate with cross‑functional teams (R&D, Quality, Production, and Supply Chain) to ensure smooth project execution and compliance with regulatory standards.
Identify opportunities for process improvement, cost reduction, and efficiency enhancement through Lean and Six Sigma methodologies.
Troubleshoot process issues and implement corrective and preventive actions (CAPA).
Participate in equipment selection, installation, and maintenance planning.
Ensure manufacturing processes comply with cGMP, FDA, and ISO quality system regulations.
Provide training and technical support to production staff on new or revised processes.
Support internal and external audits and contribute to regulatory compliance activities.
Qualifications
Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related field.
2–7 years of experience in manufacturing engineering within the medical device or biotech industry.
Strong understanding of FDA, ISO 13485, and GMP standards.
Experience with process validation (IQ/OQ/PQ), equipment qualification, and documentation control.
Proficiency in root cause analysis, FMEA, and CAPA methodologies.
Hands‑on experience with manufacturing equipment, automation, or injection molding is a plus.
Proficient in CAD tools (SolidWorks or similar) and Microsoft Office Suite.
Excellent analytical, problem‑solving, and communication skills.
Preferred Qualifications
Lean Six Sigma Green Belt or equivalent certification.
Experience with cleanroom manufacturing or Class II/III medical devices.
Working knowledge of ERP/MRP systems (SAP, Oracle, etc.).
Seniority Level Mid‑Senior level
Employment Type Contract
Job Function Other
Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
Referrals increase your chances of interviewing at Intellectt Inc by 2x
Sign in to set job alerts for “Manufacturing Engineer” roles. Lithonia, GA $115,000.00-$130,000.00 3 days ago
Warner Robins, GA $70,000.00-$85,000.00 6 days ago
#J-18808-Ljbffr