Manufacturing Associate II

Endologix

1d • $22 - $27

About The Position

We’re looking for a Manufacturing Associate II to join our manufacturing team. In this role, you’ll be 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.

Requirements

• High school diploma or GED required.
• 2–4 years of hands-on experience in medical device manufacturing, pharmaceutical production, or other regulated life sciences industry.
• Proven experience working in a cleanroom environment and following aseptic techniques.
• Demonstrated history of performing manual assembly of small, intricate components under a microscope.
• Experience maintaining compliance with FDA, ISO 13485, and GMP regulations.
• Documented use of Device History Records (DHRs), batch records, or other controlled documentation systems.
• Track record of consistently meeting production, quality, and safety targets.
• Prior exposure to in-process quality inspection, measurement tools, and defect identification.
• Knowledge of Good Manufacturing Practices (GMP) and ISO 13485 quality standards for medical device manufacturing.
• Ability to follow Standard Operating Procedures (SOPs), work instructions, and batch records with high attention to detail.
• Proficiency in using hand tools, fixtures, microscopes, and precision measurement equipment for assembly and inspection.
• Strong understanding of cleanroom protocols, gowning procedures, and contamination control.
• Demonstrated ability to perform repetitive tasks with consistency and accuracy in a regulated environment.
• Basic mechanical aptitude and ability to identify and troubleshoot minor equipment or process issues.
• Competence in documenting production activities clearly and accurately in Device History Records (DHRs).
• Good computer literacy (MS Office, ERP/MES systems preferred) for data entry and process tracking.
• Effective communication skills and ability to work collaboratively within cross-functional production teams.
• Strong problem-solving, time management, and organizational skills to meet production schedules and quality standards.
• Flexibility to work in a fast-paced environment with changing priorities and shift schedules.

Nice To Haves

• Associate degree in life sciences, engineering, or related field preferred.
• Additional coursework or certification in medical device manufacturing, GMP, or quality systems is a plus.
• Experience training or mentoring less experienced team members preferred.
• Familiarity with ERP/MES systems for production tracking and reporting.
• Ability to train and mentor entry-level manufacturing associates as needed.

Responsibilities

• Adhere to safety rules, stretching exercises, and company policies and procedures.
• 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.
• Participate in lean activities and 5S improvement efforts.
• Be familiar with terminology used in the production area.
• 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.
• May be certified as a trainer and train other production employees on manufacturing processes.
• Capability to read and interpret engineering drawings, specs and method sheets.
• Electronic systems entry.
• Perform other duties as assigned by supervisor.

Benefits

• Equity participation as approved by Board of Directors (4-year vesting schedule)
• Comprehensive health, dental, and vision insurance plans
• Generous PTO and holiday schedule
• 401(k) retirement plan with company match
• Employee wellness initiatives and mental health support
• Collaborative and inclusive company culture focused on impact and innovation
• Opportunities for career growth and internal mobility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 101-250 employees