Job Description

Job Description

Job Title: Manufacturing Engineer – Medical Devices

Location: San Diego, CA (Onsite)

Duration: 12-Month Contract (Possibility of extension)

Key Responsibilities:

• Provide engineering support to manufacturing for daily production activities, including troubleshooting, root cause analysis, and continuous improvement.
• Develop and optimize manufacturing processes, equipment, and fixtures to improve efficiency, yield, and product quality.
• Support New Product Introduction (NPI) by coordinating with R&D, Quality, and Supply Chain teams.
• Lead and execute process validations (IQ, OQ, PQ) and document validation protocols and reports per FDA and ISO 13485 standards.
• Implement lean manufacturing and Six Sigma principles to drive cost reduction and process improvements.
• Conduct time studies, line balancing, and capacity analysis for scalable production.
• Support design transfer from R&D to manufacturing, ensuring DFM (Design for Manufacturing) principles are followed.
• Collaborate with Quality and Regulatory teams during audits and inspections (e.g., FDA, ISO, MDSAP).
• Generate and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and Process Flow Diagrams.
• Evaluate new tools, technologies, and automation opportunities to enhance production capabilities.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related technical field.
• Minimum 3-5 years of experience in medical device manufacturing engineering or equivalent regulated industry.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, and cGMP compliance.
• Hands-on experience with process validation, equipment qualification, and NPI projects.
• Proficient in tools such as SolidWorks, AutoCAD, Minitab, and MS Office.
• Knowledge of Lean Six Sigma methodologies (certification preferred).
• Excellent documentation and communication skills.
• Experience with electro-mechanical assemblies, cleanroom environments, or catheter/implant manufacturing is a plus.

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