Lead Quality Engineering Specialist

hace 4 semanas

Mexicali, Baja California, México Intuitive A tiempo completo

Company Overview

At Intuitive, we are united by our mission: we believe that minimally invasive care is the care that enhances lives. Through innovation and intelligent technology, we expand the potential of physicians to heal without limitations.

As pioneers and market leaders in robotic surgery, we strive to cultivate an inclusive and diverse team dedicated to making a difference. For over 25 years, we have collaborated with hospitals and care teams worldwide to tackle some of healthcare's most challenging issues and advance what is possible.

Intuitive has been built on the efforts of remarkable individuals from diverse backgrounds. We believe that great ideas can come from anywhere: we strive to foster an inclusive culture based on diverse thoughts and mutual respect. We lead with inclusion and empower our team members to work in the best way possible and express their authentic selves.

Passionate individuals who want to make a difference drive our culture: our team members are grounded in integrity, possess a strong ability to learn, have 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, enabling us to continue advancing our mission and reach their full potential.

Join a team committed to making significant strides forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.

Job Responsibilities

  • The initial responsibilities for this role will include: 50% involvement in supporting manufacturing operations, 25% in product modifications or new product introduction projects, 15% in failure investigation, and 10% in performing complex inspections and project management.
  • Develop and implement corporate-level quality metrics.
  • Support line transfers between Intuitive facilities and regions.
  • Product Development - Manage projects of various product and subsystem types (Instruments, Accessories, product enhancements, etc.).
  • Plan and oversee the creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at ISI Mexicali and OEM suppliers, utilizing clinical and engineering expertise.
  • 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.
  • Develop and implement methods and procedures for the disposition of non-conforming materials.
  • Provide support to commercial product manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment.
  • Failure Analysis - Offer quality expertise post-market release to the quality engineering support team to analyze returned products.
  • Conduct in-depth technical failure analysis based on the physics of failure.
  • Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical/operating room environment.

Qualifications

Skills, Experience, Education, & Training:

  • Minimum Education: Bachelor’s degree in electrical, mechanical, or systems engineering, mathematics, or physics. An advanced degree is preferred.
  • Proficient in English. Effective communication skills are essential.
  • Minimum of 8+ years of experience in Quality Engineering or in a manufacturing environment, with at least 4 years in medical device design or manufacturing.
  • Strong understanding of Quality and Compliance Systems.
  • Familiarity with CFR 21 Part 820/ISO 13485 requirements for making process or design changes.
  • Solid grasp of risk assessments (Clinical/Usability risk assessments, FMEAs, etc.).
  • Ability to quickly learn the product and process and assess the impact of defects on the product.
  • Knowledge of root cause investigation processes and the ability to initiate routine problem-solving investigations.
  • Experience in Design and process improvement projects.
  • Competence in reviewing Qualification and Validation protocols.
  • Understanding of manufacturing metrics.
  • Proficient in basic Excel data analysis operations (e.g., Pareto, charts, and trends).
  • Ability to work in various project teams as the Quality Subject Matter Expert (SME).
  • Capable of communicating work tasks to various project team members.
  • Skilled in compiling data in a format suitable for presentation.
  • Personality Traits: Able to cope with changes and uncertainties; comfortable handling associated risks.
  • Willingness to bring unpleasant facts to discussions and not withhold information.
  • Results-oriented.
  • Listens to and respects others.
  • Demonstrates constructive working relationships with others in the organization.
  • Capable of setting priorities and managing time wisely, identifying critical issues from trivial ones.

Additional Information

Intuitive is an equal opportunity employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit any form of discrimination and harassment, regardless of race, sex, pregnancy status, sexual orientation, gender identity, national origin, color, age, religion, protected veteran status, disability, genetic information, or any other condition protected by applicable federal, state, or local laws.

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