Quality Engineering Manager

1 week ago

Sunnyvale, California, United States Intuitive Full time
Company Overview

At Intuitive, we are driven by our mission: we believe that minimally invasive care is transformative. Through innovation and advanced technology, we enhance the capabilities of healthcare professionals to provide care without limitations.
As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce, committed to making a positive impact. For over 25 years, we have collaborated with healthcare institutions and teams globally to tackle some of the most challenging issues in healthcare and push the boundaries of what is achievable.
Intuitive thrives on the contributions of talented individuals from various backgrounds. We recognize that great ideas can emerge from anywhere. Our culture is rooted in inclusivity, diversity of thought, and mutual respect. We prioritize inclusion and empower our team members to excel as their authentic selves.
Our culture is driven by passionate individuals who seek to make a difference. Our team members are characterized by integrity, a strong willingness to learn, the drive to accomplish tasks, and diverse real-world experiences that inspire innovative thinking. We actively invest in our team members to support their long-term development, enabling them to further our mission and reach their full potential.
Join a team dedicated to making significant advancements for a global community of healthcare professionals and their patients. Together, let’s elevate the field of minimally invasive care.

Position Overview

Key Responsibilities

This role oversees the Quality Engineering team within the Single Port Business Unit, focusing on upholding and promoting product quality. The individual will lead an organization that collaborates across the company, acting as advocates for the Product Quality mission.

Specific Duties

Manage New Product Introduction and Quality Operations for DaVinci Single Port (SP) Instruments, Accessories, and Endoscopes, including:
  • Provide quality engineering assistance on product-related challenges arising from manufacturing, utilizing appropriate quality notifications; assess the adequacy of product impact evaluations, resolutions, and any escalation results.
  • Drive continuous improvement initiatives by performing trend analysis on reported manufacturing quality notifications and/or post-market complaints.
  • Oversee the evaluation of product failures and/or non-conformances; establish metrics and promote product and/or process enhancement opportunities; lead failure investigations, review engineering evaluations, and support projects addressing these failures; identify and monitor improvement metrics.
  • Collaborate with senior leadership and cross-functional stakeholders to define strategies, priorities, and objectives for complaint reduction, cost of poor quality, trend analysis, process validation, statistical quality, and process control.
  • Provide expertise in change assessments (product and process), process validations, statistics, risk-based sampling, and measurement system analysis.
  • Partner with manufacturing teams to transition products and processes into the production environment with high quality and support these products within the production setting.
  • Evaluate the necessity for escalations regarding identified quality issues and assist team members in conducting escalation assessments and implementing necessary corrective and preventive actions, as appropriate.
  • Lead and manage the Quality Engineering team; assess skills, conduct gap assessments, prioritize team/skill development; drive talent acquisition and budgeting efforts.
  • Accountable for departmental and team member goal setting, tracking, correction, and recognition, as appropriate.
  • Represent quality management at monthly and quarterly review meetings (Quality Data & Operations Review).
In general, Quality Engineering is a stakeholder and shares responsibility for:
  • Establishing data-driven priorities for the continuous enhancement of Intuitive's products and processes.
  • Ensuring quality/reliability/safety is integrated into Intuitive's product design by collaborating with Design Engineering, Manufacturing Engineering, and Supplier Quality.
  • Guaranteeing data quality and process quality for anything impacting Intuitive's product or patient outcomes, including the improvement of SOPs, DOPs, etc.
  • Conducting risk assessments for products in the field, including recall assessments (in conjunction with Regulatory Compliance).
  • Supporting in-depth technical failure analysis, root cause analysis, resolution, and prevention for complex quality issues.
Qualifications

Skills, Experience, Education, & Training:
  • Strong understanding of medical device manufacturing operations and risk-based quality approaches.
  • Education: Engineering or Physics with a master's degree or equivalent experience.
  • Minimum of 8 years of experience, with at least 5 years in quality management within a complex medical device environment, or equivalent quality background; minimum of 1-3 years of experience in a managerial role.
  • Unwavering integrity and a strong desire to foster a collaborative work environment.
  • Demonstrated ability to build, support, and manage teams and to lead cross-functional projects.
  • Proven analytical skills evidenced by a track record of analyzing and resolving complex product and process issues.
  • Training or equivalent experience in quality science.
  • Demonstrated ability to motivate and drive initiatives across functional boundaries.
  • Proven capability to navigate conflicting requirements and make difficult trade-offs when resources are limited.
  • A commitment to performing essential tasks efficiently and effectively.
  • Excellent judgment in the face of competing priorities and incomplete information.
  • Travel requirement for this position is 10%.
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.

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.

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