Senior Quality Engineer - Multiport Da Vinci (Systems Design Control and Risk Management)

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 strong 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 :

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 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 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.

Remote Work :

No

Employment Type :

Full-time