Senior Medical Device Manufacturing Engineer - Lean

Life Science Outsourcing, Inc.; Brea, Northern (CA, KY); Hybrid; USD 140,000 - 160,000; Full time

Job summary

Life Science Outsourcing, Inc. is seeking an Experienced Manufacturing Engineer to design, integrate, and optimize medical-device manufacturing systems at our corporate office in Brea, CA.

The role focuses on improving manufacturability, reducing cost, and applying lean, Six Sigma, and validation practices. You will lead projects across product families, develop routings, BOMs, and labor standards, collaborate with customers and design teams, and ensure ISO 13485 compliance, cleanroom

Qualifications

• 7 years of Manufacturing Engineering experience in a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).
• Experience with lean manufacturing, Six Sigma, and process improvement methodologies.
• Familiarity with ISO 13485 and quality systems.
• Experience with cleanroom environments and medical devices manufacturing.
• Proficiency in designing and validating manufacturing processes, including tooling, jigs, and DFMA/DFM transfers.

Responsibilities

• Design, integrate, and improve manufacturing systems and processes for medical devices.
• Lead projects across product families, develop routings, BOMs, and labor standards.
• Apply lean principles and Six Sigma to minimize waste and optimize efficiency.
• Validate equipment and processes (IQ/OQ/PQ) and ensure packaging integrity and sterile barrier maintenance.

Education

Bachelor’s degree in Engineering or related

Tools

SolidWorks

ERP systems

Asana

Minitab

CAD/CAM

Job description

Life Science Outsourcing, Inc. is seeking an Experienced Manufacturing Engineer to design, integrate, and optimize medical-device manufacturing systems at our corporate office in Brea, CA.

The role focuses on improving manufacturability, reducing cost, and applying lean, Six Sigma, and validation practices. You will lead projects across product families, develop routings, BOMs, and labor standards, collaborate with customers and design teams, and ensure ISO 13485 compliance, cleanroom