Principal Design Quality Engineer

Overview

Join our mission-driven Quality team as the Principal Design Quality Engineer 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.

 

 

ABOUT THE ROLE:

 

The Principal Design Quality Engineer will serve as a key technical leader ensuring that implantable vascular medical devices meet the highest standards of safety, quality, and regulatory compliance. This role requires deep expertise in product development processes and regulatory frameworks governing medical device design.

Responsibilities

WHAT YOU'LL DO:

 

Design Quality Leadership:

• Drive and oversee design control activities throughout the product lifecycle, ensuring compliance with ISO 13485:2016 and 21 CFR Part 820.
• Partner with R&D to embed quality into product design and development processes for efficiency and effectiveness.

Risk Management:

• Lead risk analysis and mitigation strategies in accordance with ISO 14971:2019.
• Ensure robust documentation of hazard identification and risk controls.

Regulatory Compliance:

• Maintain thorough understanding and application of international standards and regulations, including ISO 10993 (biocompatibility), ISO 62366-1:2015 (usability engineering), and other applicable global requirements.
• Support regulatory submissions and audits by providing accurate, compliant documentation.

Product Development Process Optimization:

• Champion best practices for efficient and effective product development, including design verification, validation, and transfer to manufacturing.
• Identify opportunities for process improvements and implement solutions that enhance quality and reduce time-to-market.

Cross-Functional Collaboration:

• Work closely with engineering, manufacturing, regulatory, and clinical teams to ensure alignment on quality objectives.
• Mentor junior engineers and provide technical guidance on design quality principles.

Continuous Improvement:

• Monitor quality metrics, analyze trends, and implement corrective/preventive actions to strengthen compliance and product reliability.

Other:

• Perform other duties as assigned by supervisor.

Qualifications

WHAT YOU'LL BRING:

 

Education:

• Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, or related field or 15+ years medical device experience.

Experience:

• Minimum 10 years in design or quality engineering for implantable medical devices, preferably vascular implants.
• Experience with regulatory submissions (510(k), PMA) and global compliance, preferred.

Skills/Competencies:

• In-depth knowledge of ISO 13485:2016, ISO 14971:2019, ISO 10993, ISO 62366-1:2015, FDA 21 CFR Part 820, and other international regulations.
• Strong understanding of design control, risk management, usability engineering, and biocompatibility requirements.
• Professional certifications (CQE, ISO Lead Auditor, Six Sigma), preferred.
• Familiarity with sterilization processes and packaging validation, preferred.
• Excellent problem-solving, analytical, and communication skills.
• Proven ability to lead complex projects and influence cross-functional teams.

 

HOW YOU'LL SHOW UP:

 

All In: Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of