Sr. Manufacturing Engineer (Santa Rosa)

Sr. Manufacturing Engineer

Join our high-impact manufacturing team at Endologix as a Sr. Manufacturing Engineer!

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 trainingsupported 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 innovationand 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.

Responsibilities

What You'll Do :

• Design and develop manufacturing processes for new products and / or changes to existing products.
• Design and develop fixtures and tooling for manufacturing process.
• Develop and execute process validation protocols (IQ / OQ / PQ).
• Analyze process data and make decisions / recommendations relating to process capability and DFM.
• Perform Installation Qualification (IQ) equipment protocols and reports.
• Investigate benefits and features of capital equipment and generate capital appropriation justifications.
• Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
• Provide engineering support to production department in troubleshooting and resolving technical problems.
• Contact and address component and / or raw material issues with suppliers.
• Support manufacturing and quality with addressing NCMR issues.
• Plan, schedule, and complete projects in a manner consistent with business objectives.
• Contribute to the intellectual property position of the company via invention and patent applications.
• Maintain accurate documentation of concepts, designs, and processes.
• Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
• Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
• Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved.
• Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Ensure that all regulatory and internal policies are followed.
• Assist engineering manager in development of engineers providing assistance with coaching and mentoring.
• Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
• Perform other duties as assigned by supervisor.

Qualifications

What You'll Bring : Education :

Experience :

Skills / Competencies :

How You'll Show Up :

All In : Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of your work. Move with urgency, deliver on your promises, and lead with boldness and passion.

Act with Integrity : Prioritize ethics and transparency in every decision. Earn trust by being honest, respectful, and dependable working diligently to uphold the confidence of your colleagues, customers, and communities.

Tenacious : Meet challenges head-on with resilience and resolve. Stay focused, push through obstacles, and consistently look for solutions, not excuses.

Pioneering : Challenge the status quo and embrace innovation. Develop new ideas, test bold solutions, and pave the way for others driving progress through curiosity and creativity.

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 :

Plus :

Our Commitment to Diversity & Inclusion :

Endologix LLC is an Equal Opportunity 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.