Quality Engineer 2

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

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, PowerBI, etc.

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 employees
who 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 government’s 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 employee’s
start 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.