Medical Device Quality Engineer

3 days ago


Sunnyvale, California, United States Intuitive Full time
Our Company
Intuitive is a global leader in robotic-assisted surgery, committed to advancing the world of minimally invasive care. With a strong focus on innovation and patient outcomes, we strive to create technologies that empower surgeons to heal without constraints.

As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of our products, which will ultimately benefit patients and healthcare professionals worldwide.

Job Summary
We are seeking an experienced Quality Assurance Specialist to join our team. This role will involve developing and implementing quality metrics, specifications, and standards across our product lines. The successful candidate will possess a strong background in quality engineering and a high level of technical expertise in at least one or two technical specialties applicable to medical robotics.

Key Responsibilities
- Develop and apply corporate-level quality metrics
- Drive and project manage quality initiatives in product development and manufacturing
- Collaborate with design engineering teams to ensure compliance with regulatory requirements
- Participate in risk analyses for new and existing products

Requirements
The successful candidate must possess a minimum of 4+ years of experience in Quality Engineering or a related field, with a minimum of 3 years in a medical device design or manufacturing environment. A bachelor's degree in electrical, mechanical, or system engineering, math, or physics is required. Advanced degrees are preferred.

The ideal candidate will have experience in high-volume capital equipment/NCR environments and demonstrate a strong understanding of CFR 21 820/ISO 13485 requirements. They should also be able to navigate quality and compliance systems with minimal oversight and possess excellent problem-solving skills.

What We Offer
We offer a competitive salary range of $120,000 - $160,000 per year, depending on experience. Other benefits include a comprehensive health insurance package, retirement plan, and generous paid time off. We also offer professional development opportunities to help you grow your career within the company.

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