Staff Quality Engineer New Product Development

Primary Function of Position
This role drives enterprise level quality outcomes by leading strategic initiatives shaping quality practices and influencing decisions across business units. The Staff QE operates with broad autonomy and is recognized as a technical and leadership authority.

Essential Job Duties
Leads initiatives that change how quality is executed across multiples BUs or sites
Establishes standards frameworks or methodologies adopted beyond local teams
Serves as escalation owner for high impact product quality & compliance risks
Leadership of critical product process investigations and audits.
Indentification execution and advise on strategic quality projects with company wide impact.
Ownership of quality investigations for complaints and non-conformances.
Author review and approve QA documentation protocols
Leadership of critical CAPAs
Serves as subject matter expert in critical audits.
Analyze and interpret advanced quality data and KPI trends.
Mentor junior and senior engineers in technical expertise.
Ensure compliance with company and regulatory standards (GMP ISO FDA). Provides industry expertise.
Advise cross-functional teams on quality requirements.
Indentification and ownership of continuous improvement projects.
Design Control and Risk Management Stewardship: Planning and execution of design controls risk management and
design verification/validation for new products
o Advocate product design history file and ensure compliance with internal processes and external standards and
regulations.
o Understand user needs and assure they are translated to the design while ensuring compliance with usability
and human factors standards and regulations.
o Partner with engineering to define design inputs design outputs and traceability matrices.
o Contribute to the strategy and execution of risk-based design verification and validation.
o Accountable for overall risk management file: participate and support the development of product risk
management file to analyze and assess the product risks associated with user design process and supplier.
Support design controls activities associated with new product development. Advocate and ensure the transfer of
reliable and scalable designs to manufacturing
o Review and provide feedback on design architecture selections requirements and drawings from early
design.
o Collaborate with manufacturing purchasing test engineering and supplier engineering to facilitate transfer of
scalable designs into production.

Breadth of Impact and Leadership
Demonstrated impact at BU or enterprise level
Outcomes are adopted and sustained beyond the business unit
Develops other Senior QEs into future Staff level leaders
Influences senior leadership decisions through data judgment and presence
Acts as a role model for quality culture and leadership behaviors

Qualifications :

Required Experience and Education
Minimum 12 years of experience in QE/QA and bachelors degree in engineering or relevant discipline or equivalent combination of education and experience
Required Knowledge Skills and Abilities
Advanced understanding of quality principles and methodologies
Advanced data analysis and data interpretation skills
Expert ability to resolve quality issues
Respected ability to foster a quality culture
Expert communication and team collaboration ability to influence stakeholders executive presence
Expertise with evolving quality standards tools and technologies
Strong ability to mentor and teach junior engineers
Physical Requirements
Office lab production and site travel as needed.
Frequent computer and inspection work.
Occasional lifting (<25 lbs) and PPE for production or regulated areas.

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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