Manufacturing Associate III

Endologix, Inc.; Santa Rosa (CA); On-site; USD 42,000 - 62,000; Full time

Job summary

Endologix, Inc. is seeking an assembly technician to build medical devices following approved manufacturing processes. You will use hand tools, calibrated instruments, and test fixtures to assemble components and ensure quality in a controlled environment.

The role requires basic math and strong attention to detail, with adherence to GMP and GDP standards. Training will be provided, and collaboration with engineers and supervisors is expected.

Qualifications

• High School Diploma or equivalent.
• Demonstrates basic English reading, writing and spoken skills.
• Basic math.

Responsibilities

• Assemble product using small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• Identify and communicate safety, quality, process issues or concerns.
• Maintain clean, controlled environment and proper attire according to GMP/GDP.

Skills

English literacy

Hand tool use

Quality awareness

Education

High School Diploma or equivalent

Job description

Overview

Responsible for assembling high quality medical devices in accordance with approved manufacturing process instructions and Standard Operating Procedures, assisting in the evaluation and resolution of line issues, and suggesting possible method / process improvements. Other job duties will be assigned as needed.

Responsibilities

• Comply with Endologix’s policies, procedures, and quality standards as well as stretching exercises, safety and environmental regulations.
• Assemble product as required utilizing small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• Identify and communicate any safety, quality, process issues or concerns as needed.
• Maintain controlled environment integrity by using proper attire and adherence to controlled environment practices and procedures.
• Perform in-process quality checks as required while giving timely feedback as issues arise
• Recognize and report any unacceptable materials and/or sub-assemblies to engineering and/or supervisor.
• Responsible for 100% compliance to Endologix Quality and Regulatory policies and adhere to Endologix Core Values.
• Responsible for quality of work and adhering to manufacturing methods and quality records.
• Understand and comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Work with supervisors, engineers and technicians to resolve line issues and suggest improvements.
• Be familiar with terminology used in the production area.
• Participate in lean activities and 5S improvement efforts.
• Understand and demonstrate Lean manufacturing techniques and principles.
• Actively pursue resolution of issues by collaborating with and utilizing all resources.
• Aware of common defects within manufacturing departments and the results caused by variations during the manufacturing processes.
• Capable of moving from one station to another without continuous mistakes
• Be certified as a trainer and train other production employees on manufacturing processes.
• Coach and provide guidance to others on manufacturing processes and standard operating procedures.
• Capability to read and interpret engineering drawings, specs and method sheets.
• Electronic systems entry.
• Support supervisor, as required.

Qualifications

· High School Diploma or equivalent

· Demonstrates basic English reading, writing and spoken skills

· Basic math