Manufacturing Associate II

Endologix; Santa Rosa (CA); In loco; USD 30.000 - 34.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive pay

Solid benefits

Career growth opportunities

Culture that cares

Descrizione del lavoro

Endologix LLC in Santa Rosa, CA—a federal contractor—seeks a Manufacturing Associate II to join our mission-driven team assembling high-quality medical devices per approved processes. You will help resolve line issues, contribute to process improvements, and ensure GMP and GDP compliance in a cleanroom environment.

Ideal candidates have 2–4 years in medical device manufacturing or regulated life sciences, experience handling microscopes and precision tools, and a track record of quality, safety,

Competenze

• Must have 2–4 years in medical device manufacturing or regulated life sciences.
• Experience in cleanroom environments and aseptic technique.
• Experience with manual assembly under a microscope.
• Familiarity with FDA, ISO 13485, and GMP regulations.

Mansioni

• Follow safety guidelines and company policies for a safe workplace.
• Assemble products using hand tools, microscopes, and fixtures with precision.
• Identify and communicate safety/quality concerns promptly.
• Maintain cleanroom attire and procedures to protect product quality.
• Perform in-process quality checks and provide timely feedback.
• Document nonconforming materials and ensure proper follow-up.
• Take ownership of work quality and maintain accurate quality records.
• Comply with GMP and GDP in all documentation.
• Collaborate with supervisors, engineers, and technicians to resolve line issues.
• Engage in lean and 5S initiatives to improve production.

Conoscenze

GMP knowledge

Attention to detail

Team collaboration

Good documentation

Formazione

High school diploma or GED

Associate degree preferred

Strumenti

MS Office

ERP/MES systems

Descrizione del lavoro

Overview

Join our highly motivated, mission-driven Manufacturing team as Manufacturing Associate II at Endologix!

WHO WE ARE:

Endologix LLC is a California-based global medical device company dedicated to improving patients’ lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training-supported by industry-leading clinical evidence. At Endologix, we’re driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health.

What sets us apart is not just our technology, but our culture. At Endologix, we foster a collaborative, mission-driven environment where every team member plays a vital role in advancing patient care. We value integrity, tenacity, and innovation—and we support our people with the tools, trust, and training they need to grow and continuously learn. If you're passionate about making a meaningful impact in healthcare, you’ll find purpose and belonging here.

Our Core Valuesare the guiding principles informing our choices and actions, because our customers and patients depend on us:

• Patient Outcomes Drive Us:We improve lives with every advancement we deliver.

• Integrity Defines Us:We dowhat'sright, stay transparent, prioritize quality, and own our actions.

• Innovation Advances Us:We stay curious, adaptable, and push boundaries.

• Boldness Propels Us:We take smart risks and are unafraid in our pursuit of excellence.

• Collaboration Unites Us:We partner across teams and with physicians to drive exceptional results.

ABOUT THE ROLE:

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.

Responsibilities

WHAT YOU'LL DO:

• Follow all safety guidelines, stretching routines, and company policies to ensure a safe and consistent work environment that supports reliable product performance and positive outcomes.
• Assemble products using small hand tools, calibrated instruments, microscopes, and test fixtures, maintaining a high level of precision and care to ensure consistent quality.
• Identify and communicate safety, quality, or process concerns promptly, demonstrating accountability and a commitment to doing what is right.
• Maintain controlled environment integrity by adhering to proper attire and cleanroom procedures, protecting product quality and overall process reliability.
• Perform in-process quality checks and provide timely feedback, supporting early detection of issues and continuous improvement in manufacturing performance.
• Recognize and report nonconforming materials or subassemblies, ensuring concerns are addressed with transparency and appropriate follow-up.
• Take ownership of work quality by adhering to established manufacturing methods and maintaining accurate, complete quality records.
• Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), reinforcing consistency, traceability, and trust in all documentation.
• Collaborate with supervisors, engineers, and technicians to resolve line issues and contribute ideas that enhance efficiency and product quality.
• Participate in lean and 5S initiatives, supporting innovation and continuous improvement within the production environment.
• Build familiarity with production terminology, common defects, and process variations, applying knowledge to improve accuracy and reduce risk.
• Demonstrate flexibility by moving between workstations while maintaining quality and minimizing errors.
• Train and support team members when certified, promoting knowledge sharing and strengthening overall team performance.
• Read and interpret engineering drawings, specifications, and method sheets to ensure alignment with design and manufacturing requirements.
• Accurately complete electronic system entries to maintain traceability and support data-driven decision-making.
• Take on additional responsibilities as assigned, demonstrating initiative, adaptability, and a willingness to step in where needed.

Qualifications

WHAT YOU'LL BRING:

Education:

• High school diploma or GED required.
• 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:

• 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.
• Experience training or mentoring less experienced team members preferred.
• Familiarity with ERP/MES systems for production tracking and reporting.

Skills/Competencies:

• 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.
• Ability to train and mentor entry-level manufacturing associates as needed.
• Flexibility to work in a fast-paced environment with changing priorities and shift schedules.

WHAT WE OFFER:

At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That’s why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You’ll be part of a team that’s making a real impact on patients’ lives. When you join us, you’re not just taking a job, you’re building a meaningful career with a team that’s invested in your success.

The compensation package includes:

• Hourly rate of $21.63/hr-$24.64/hr

EndologixLLC is an Equal Opportunity and affirmative Action Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor,EndologixLLC is committed to taking affirmative action to recruit, employ, and advance inemploymentqualified individuals with disabilities and protected veterans.