Quality Engineer

Position: Quality Engineer 2
Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

Primary Function of Position The Quality Engineer II supports product development from concept through commercialization and will serve as the core team member with the cross-functional product development team. The Quality engineer will provide support for design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an active role to ensure that the developed products meet quality standards consistent with Intuitive' s quality processes, while meeting design control and regulatory requirements.

Essential Job Duties

• Work closely with product development teams.
• Monitor priorities and tracks progress against schedules; and communicates status to management.
• Provide support in the implementation and policing of GMP, ISO and FDA requirements.
• Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process Validation
• Experience with product investigation, Identifying root cause and implementing appropriate solutions
• Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)
• Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
• Experience with computerized systems, such as SAP, Trackwise, Agile, etc.
• Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Support internal and external audits, including preparation and direct interaction with auditors.
• Support manufacturing and work cross-functionally to resolve technical problems
• Support, designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
• Author technical documents with sufficient clarity, detail and correctness
• Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
• Other duties as assigned

Qualifications

Qualifications

Required Skills and Experience

• Minimum Education:
  
  Bachelor's in engineering or STEM
• Advanced degree preferred with 2+ years of working experience in Quality Engineering or related field, minimum 2 years in medical device environment.
• Experience and familiarity with respect to design control and risk management from early design and development through commercialization.
• Demonstrated experience with electromechanical devices.
• Experience with medical standards: ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization.
• Able to navigate quality system with minimal oversight on individual projects.
• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.
• Able to articulate complex information to teams, including managment

Required Education and Training

• Minimum BS in Engineering or STEM discipline is required.
• Minimum 3 years of experience in a regulated industry with 1 years in Medical Device

Preferred Skills and Experience

• Experience with data analysis tool. i.e., Tableau, Power
  
  BI, etc.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable…