Manufacturing Associate III
Endologix LLC · Portola Valley, California, United States · 1 mo ago
Engineering$25–$30/hrFull-time
About the role
We're looking for a talented Manufacturing Associate III to join our high-impact manufacturing team. In this role, you’ll be responsible for the efficient and accurate assembly of high-quality medical devices in compliance with approved Manufacturing Process Instructions (MPIs), Standard Operating Procedures (SOPs), and quality standards.
Responsibilities
- Assemble medical device products using small hand tools, calibrated instruments, microscopes, measurement devices, and test fixtures.
- Ensure full compliance with Endologix policies, procedures, and quality standards, including safety regulations, environmental protocols, and required stretching exercises.
- Maintain cleanroom and controlled environment integrity through proper attire and adherence to controlled environment practices.
- Perform in-process quality checks and promptly report any safety, quality, or process-related concerns.
- Identify and escalate unacceptable materials and sub-assemblies to Engineering and/or the Supervisor.
- Ensure complete compliance with Endologix Quality and Regulatory policies and Core Values.
- Take ownership of product quality by strictly following manufacturing instructions and completing quality records accurately.
- Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Collaborate with supervisors, engineers, and technicians to troubleshoot line issues and implement process improvements.
- Understand and use production terminology and demonstrate awareness of common manufacturing defects and their impact.
- Exhibit flexibility by performing effectively across multiple assembly stations with minimal errors.
- Participate actively in Lean Manufacturing and 5S initiatives to enhance efficiency and workplace organization.
- Proactively engage cross-functional resources to resolve production issues.
- Read and interpret engineering drawings, specifications, and method sheets accurately.
- Enter data into electronic systems as required for documentation and tracking.
- Serve as a certified trainer for manufacturing processes; train and mentor other production employees.
- Provide coaching and guidance to peers on standard operating procedures and assembly techniques.
- Support supervisors as needed, including participating in leadership tasks and line coordination.
- Perform other duties as assigned by supervisor.
Qualifications
- Education: High school diploma or equivalent required; associate or technical degree preferred.
- Experience: 3–5 years of experience in a regulated manufacturing environment, preferably in the medical device industry. Experience working within a clean room environment. Lean & 5S experience desired.
- Skills/Competencies: Strong attention to detail and ability to follow complex instructions and procedures. Demonstrated ability to troubleshoot line issues and work independently with minimal supervision. Effective communication skills and the ability to collaborate within a team environment. Familiarity with lean manufacturing principles and continuous improvement methodologies is a plus.
Benefits
- Compensation Package Includes: Hourly rate of $25.00/hr-$30.00/hr, Discretionary bonus, 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, Plus Employee wellness initiatives and mental health support.