Manufacturing Engineer – Medical Device (Process Validation, NPI, Lean)

Stark Pharma Solutions Inc; Irvine (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Manufacturing Engineer for a medical device manufacturing environment to support production operations and drive process improvements. The role emphasizes process validation, NPI, and lean initiatives within an ISO 13485 context.

The position requires a bachelor's degree in engineering, 3–5 years of medical device manufacturing experience, and familiarity with IQ/OQ/PQ, ISO 13485, and 21 CFR Part 820. CAD/SolidWorks and GD&T knowledge are preferred.

Qualifications

• Bachelor's degree in Mechanical, Industrial, Biomedical or Manufacturing Engineering.
• 3–5 years of manufacturing engineering experience in medical devices.
• Experience with process validation (IQ/OQ/PQ).
• Working knowledge of ISO 13485 and 21 CFR Part 820.
• CAD experience with SolidWorks preferred and knowledge of GD&T.
• Lean Manufacturing and Six Sigma exposure.
• Must be legally authorized to work in the United States.
• W2 employment only.

Responsibilities

• Support daily production operations and troubleshoot process and equipment issues on the manufacturing floor
• Execute process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes
• Drive process improvement initiatives to improve yield and reduce scrap and cycle time
• Design and qualify tooling and fixtures to support production
• Develop and update work instructions, routers and manufacturing documentation
• Support new product introduction (NPI) and transfer to manufacturing
• Process engineering change orders (ECO/ECN) and assess manufacturing impact
• Support non-conformance and CAPA investigations related to manufacturing processes

Skills

Process validation

Lean Manufacturing

Six Sigma exposure

Troubleshooting

Education

Bachelors degree in Mechanical, Industrial, Biomedical or Manufacturing Engineering

Tools

CAD experience (SolidWorks preferred)

GD&T

Job description

About Company

Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.

Manufacturing Engineer Medical Device (Process Validation, NPI, Lean)

Job Summary

Our client, a medical device manufacturer, is seeking a Manufacturing Engineer to support production operations and process improvement on the manufacturing floor. The role covers process validation, tooling and fixture support, new product introduction and day-to-day troubleshooting in an ISO 13485 environment.

Responsibilities

• Support daily production operations and troubleshoot process and equipment issues on the manufacturing floor
• Execute process validation activities (IQ/OQ/PQ) for manufacturing equipment and processes
• Drive process improvement initiatives to improve yield and reduce scrap and cycle time
• Design and qualify tooling and fixtures to support production
• Develop and update work instructions, routers and manufacturing documentation
• Support new product introduction (NPI) and transfer to manufacturing
• Process engineering change orders (ECO/ECN) and assess manufacturing impact
• Support non-conformance and CAPA investigations related to manufacturing processes

Qualifications

• Bachelor's degree in Mechanical, Industrial, Biomedical or Manufacturing Engineering
• 3 5 years of manufacturing engineering experience in medical device
• Experience with process validation (IQ/OQ/PQ)
• Working knowledge of ISO 13485 and 21 CFR Part 820
• CAD experience, SolidWorks preferred, and working knowledge of GD&T
• Lean Manufacturing and Six Sigma exposure
• Must be legally authorized to work in the United States
• W2 employment only