Quality Engineer 3

Primary Function of Position:

As Intuitives da Vinci Surgical System continues to be adopted by an increasing number of hospitals surgeons and patients we are building a dedicated team to drive reliability quality and safety to ever-higher levels. This commitment spans products in use in manufacturing and in design.

Join us in advancing our quality mission by bringing your hands-on experience solving complex engineering challenges your fascination with sophisticated electro-mechanical systems and your passion for best practices in designing monitoring and improving products and processes.

Intuitive seeks a strong technical contributor who can:

• Define practical impactful quality metrics and specifications.
• Identify key opportunities for product improvement.
• Launch and lead quality initiatives and projects.
• Serve as an expert consultant to resolve the most technically challenging quality issues.

The ideal candidate has broad experience and deep technical expertise in at least two specialties relevant to medical robotics. You should be equally comfortable in the test lab and providing technical leadership as we develop organizational standards. You will reject unnecessary process red tape instead championing efficient methods to build quality into our products. Additionally you will coach mentor and influence engineering teams in best practices for quality data analysis protocol development and design for reliability.

Essential Job Duties

Design Controls and Risk Management

•  Support planning and execution of design controls risk management and design verification/validation for new products.
•  Assist in developing the Design History File (DHF) and ensure compliance with internal processes and external standards/regulations.
•  Assist in translating user needs into design requirements while ensuring compliance with usability and human factors standards.
•  Collaborate with engineering to define design inputs outputs and maintain traceability matrices.
•  Contribute to risk based design verification and validation activities.
•  Support development of the product Risk Management File analyzing risks related to user design process and suppliers.

Design Transfer and Manufacturing Readiness

•  Review design architectures requirements and drawings during early development stages.
•  Partner with manufacturing purchasing test engineering and supplier engineering to enable smooth transfer of designs into production.
•  Assist in supplier selection qualification certification and performance improvement initiatives.
•  Participate in Technical Reviews and Design Reviews for new product development.

Regulatory and Compliance Support

•  Collaborate with Regulatory Affairs to prepare submissions and respond to regulatory inquiries.
•  Support internal and external audits including preparation and direct interaction with auditors.

Qualifications :

Required Skills and Experience 

• Bachelors degree in Engineering or related field (Mechanical Electrical Biomedical); advanced degree preferred.
• 5 years of experience in Quality Engineering including at least 3 years in a medical device design or manufacturing environment.
• Strong understanding of CFR 21 Part 820 and ISO 13485 requirements for process and design changes.
• Expertise in product risk management including generating design and process FMEAs.
• Proficient in Design Controls Change Controls and engineering processes.
• Skilled in developing and executing qualification/validation protocols and quality assurance procedures.
• Experience leading product containment and rework activities.
• Proficient in statistical methods and tools such as Minitab to support validation and quality decisions.
• Advanced Excel skills (e.g. VLOOKUP PivotTables PivotCharts) for multi-source reporting trend analysis and data interpretation.
• Independent thinker capable of making decisions with limited information.
• Strong leadership in initiating improvement discussions and driving team success.
• Effective communicator with experience presenting to cross-functional teams and management (e.g. report writing presentations QRB).

Required Education and Training 

• Bachelors degree in Engineering or related field (Mechanical Electrical Biomedical); advanced degree preferred.

Working Conditions

• none

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

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time