Senior Quality Engineer

Primary Function of Position The Staff Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Staff Quality engineer will provide expertise and guidance to the team on design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements.

Essential Job Duties

• Engage and manage multi-level and multi-discipline project work teams

• Develops and implement projects to achieve targets and tracks progress against schedules; and communicates status to management

• Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA requirements

• High Level of Proficiency with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validation

• Proficiency with advanced 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

• Outstanding organizational, communication, presentation, and interpersonal skill

• Solid contributor to the planning and execution of design controls, risk management, and design verification/validation for new products

• Ensure reliable and scalable Designs to transferred to manufacturing by supporting Design for Reliability and Manufacturing activities.

• Support Regulatory Affairs with creating submissions and responding to submission questions.

• Support internal and external audits, including preparation and direct interaction with auditors.

Required Skills and Experience

• Minimum Education: Bachelor’s in engineering or STEM

• Advanced degree preferred with minimum 6 years of working experience in Quality Engineering or related field, minimum 5 years in medical device design environment.

• Solid understanding of design control and risk management from early design and development through commercialization; Demonstrated experience with electromechanical system from concept through launch is required.

• Experience with medical standards compliance, including 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 personal projects.

• Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.

• Solves complex problem with minimal oversight.

• Able to articulate complex information to teams, including executive management

Required Education and Training

• Minimum BS in Engineering or STEM discipline is required.

• Minimum 5 years of experience in a regulated industry with 3 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 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 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.

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 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.

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.