Software Quality Engineer - 3

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 strong quality functional leader to support the projects associated with the development of next generation products.

Quality Engineer 3 supports product development from concept through commercialization and serves as a core team member of the crossfunctional software development team. This role provides expertise and guidance on software development lifecycle design controls risk management anomaly tracking and code reviews. Additionally the position ensures the compliance reliability and safety of software used in our medical devices.

Roles & Responsibilities:

• Software Quality Assurance & Compliance
  • Develop implement and maintain software quality processes in compliance with ISO 13485 FDA 21 CFR Part 820 IEC 62304 ISO 14971 and MDR.
  • Participate in design reviews code reviews defect tracking and reviews and software validation activities.
  • Ensure adherence to software development lifecycle (SDLC) processes including Agile methodologies.
• Risk Management
  • Support risk management activities in accordance with ISO 14971 IEC 62304 and ISO 800021
  • Collaborate with R&D and testing teams to identify and mitigate software defects.
  • Ensure the completeness and full coverage of software verification and validation (V&V) protocols including unit testing integration testing and system testing.
• Design Control
  • Participate in and support the development of the product design history file ensuring compliance with internal processes and external standards and regulations.
  • Partner with engineering to define design inputs design outputs and traceability matrices.
• 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 & CrossFunctional Collaboration
  • Drive continuous improvement in software quality processes and methodologies.
  • Work closely with software development regulatory affairs manufacturing and postmarket teams to ensure highquality software delivery.
  • Implement test automation strategies to improve efficiency and coverage.

Qualifications :

Skills Experience Education & Training:

• Requires a minimum of 6 years of related experience with a University Degree (in Computer science software engineering biomedical engineering or 4 years of relevant experience and an Advanced Degree (in electrical mechanical or system engineering math or physics)
• Expertise in medical device standards such as IEC 62304 ISO 800021 ISO 14971 IEC 60601 and FDA Design Controls.
• Experience with riskbased software validation software test automation and SDLC processes.
• Preferred experience in AI/MLbased medical software (SaMD/embedded AI).
• Knowledge of cybersecurity and data privacy (IECISO 27001 NIST GDPR HIPAA).
• Ability to navigate quality systems with minimal oversight on individual projects.
• Balanced risk decisionmaking 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 COVID19. 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 marketcompetitive 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 COVID19.  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 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 marketcompetitive 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.

Remote Work :

No

Employment Type :

Fulltime