Senior Quality Engineer (Design Controls and V&V)

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

Intuitive Surgical designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. We are looking for a proven quality functional leader to support the projects associated with the development of next generation products.

The Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional product development team. This role provides expertise and guidance on design controls, risk management, process validation, and design for reliability and manufacturing. Additionally, the position ensures that developed products meet quality standards consistent with Intuitive’ s quality processes and all external design control and regulatory requirements.

Roles & Responsibilities:

• Design Controls and Risk Management:
  • Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
  • Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
  • Understand user needs and ensure they are translated into the design, while complying with usability and human factors standards and regulations.
  • Partner with engineering to define design inputs, design outputs, and traceability matrices.
  • Contribute to the strategy and execution of risk-based design verification and validation.
  • Participate in and support the development of the product risk management file, analyzing and assessing product risks associated with user, design, process, and supplier.
  • Design Transfer:
    • Ensure reliable and scalable designs are transferred to manufacturing.
    • Review design architectures, selections, requirements, and drawings from early design stages.
    • Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate the transfer of scalable designs into production.
    • Assist in supplier selection, qualification, certification, and performance improvement.
    • Contribute to new product development Technical Reviews and Design Reviews.
    • Regulatory Support:
      • Support Regulatory Affairs with creating submissions and responding to submission questions.
      • Support internal and external audits, including preparation and direct interaction with auditors.
      • Process Improvement & Cross-Functional Collaboration
        • Support continuous improvement in design control & risk management quality processes and methodologies.

Qualifications

Skills, Experience, Education, & Training:

• Requires a minimum of 8 years of related experience with a University Degree (in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, biomedical engineering), or 5 years of relevant experience and an Advanced Degree
• Expertise in medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls. Previous experience risk-based V&V, process validation, limit/challenge testing is required
• Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred
• Previous experience with running Verification & Validation Testing is preferred.
• Ability to navigate quality systems with minimal oversight on individual projects.
• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
• Ability to solve complex problems with minimal oversight. Ability to articulate complex information to teams, including executive management.

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 Employment 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 laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

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 Employment Opportunity. 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 laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.