Senior Quality Engineer - Medical Device

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Roles & Responsibilities:

This position has responsibility for:

60% Sustaining, 30% QMS, 10% Ad Hoc

• Development and application of corporate level quality metrics and reports.
• MVP for building, product, and process for a new facility.
• Drive and project manage quality initiatives in one or more of these focus areas:
• Quality Management System Development
• Product Quality
• Production validation planning, execution, and documentation.
• Quality Advocacy and Project Management.
• Process Quality
• Data Quality

Product Support

• Handle projects of various product and subsystem types (System, Instruments, Accessories, Software, Hardware, Mechanical, Vision, new products, product improvements, etc).
• Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data.
• Support product transfer projects, transfer and implement quality assurance procedures, sampling plans, methods, equipment and processes.
• Provide support to commercial product distribution and support to manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
• Supports internal and external audits.
• Responds to quality escalations and provides technical support for troubleshooting, repair and testing.
• Escalates to direct management all quality issues that could impact patient safety or surgical efficacy.
• Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk.

Failure Analysis

• Perform risk analysis and completes quality disposition for variance requests and non-conformances.
• Perform technical failure analysis based on the physics of failure.

QMS

• Support gap analysis between Chinese regulations and ISI processes.
• Establish new processes or modify existing processes to ensure regulatory compliance.

Qualifications

Skill/Job Requirements:

• Capable of compiling data in format appropriate for presentation.
• Minimum 4 years in medical device design or medical device manufacturing environment.
• Involved in Design and process improvement projects in the past.
• Minimum 8+ years of working experience in Quality Engineering, or in manufacturing environment
• Able to work in various project teams as the Quality SME.
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g. Pareto, charts and trend).
• Able to learn, at a fast pace, the complex product and process and assesses defects’ impact to product.
• At least a Bachelor’s degree in electrical, mechanical, biomedical, or system engineering, math, or physics. Advanced degree preferred.
• Understands root cause investigation process and able to initiate routine problem-solving investigations.
• Able to communicate work tasks to various project team members.
• Experience in writing and reviewing Qualification and validation reports
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including FDA CFR 21 820, ISO 13485 and others.
• Have good grasp of quality control and tools.

Preferred Skills:

• Understanding Chinese Product Technical Requirements is a plus.
• Bilingual English-Mandarin verbal and written skills are a plus
• Familiar with Chinese NMPA Decree 739, Order 53, and related standards and guidelines is a plus.

Personality Requirements

• Minimum Education: Bachelor’s degree in electrical, mechanical, biomedical, or system engineering, math, or physics. Advanced degree preferred.
• Able to work in various project teams as the Quality SME.
• Have good grasp of quality control and tools.
• Involved in Design and process improvement projects in the past.
• Understands root cause investigation process and able to initiate routine problem-solving investigations.
• Capable of compiling data in format appropriate for presentation.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including FDA CFR 21 820, ISO 13485 and others.
• Experience in writing and reviewing Qualification and validation reports
• Minimum 8+ years of working experience in Quality Engineering, or in manufacturing environment, minimum 4 years in medical device design or medical device manufacturing environment.
• Able to communicate work tasks to various project team members.
• Understands manufacturing metrics.
• Understands basic Excel data analysis operations (e.g. Pareto, charts and trend).
• Able to learn, at a fast pace, the complex product and process and assesses defects’ impact to product.

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 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 below:

Base Salary Range Region 1:$131,400 - $189,000
Base Salary Range Region 2: $111,700 - $160,700
Shift: Day
Travel: 25% of the time