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Manager, Quality Engineering

3 months ago

Sunnyvale, United States Intuitive Full time
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.

Job Description

Primary Function of Position

This person manages the Quality Engineering group within the Single Port Business Unit and is responsible for maintaining and advocating product quality, drives an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission.

Roles & Responsibilities

Drives New Product Introduction and Quality Operations for DaVinci Single Port (SP) Instruments, Accessories, and Endoscopes, responsibilities include:

  • Provide quality engineering support on product related issues arising from manufacturing using appropriate quality notifications; verify the adequacy of product impact assessments, dispositions, and any escalation outcomes.
  • Drive continuous improvement initiatives by conducting trend analysis on reported manufacturing quality notifications and/or post market complaints.
  • Oversee the analysis of product failures and/or non-conformances; establish metrics and drive product and/or process improvement opportunities; drive failure investigations, review engineering assessments, and support projects that address said failures; identify and track metrics of improvement.
  • Work with senior leadership and cross-functional stakeholders to establish strategies, priorities, and goals for complaint reduction, cost of poor quality, trend analysis, process validation, statistical quality, and process control.
  • Provide subject matter expertise with change assessments (product and process), process validations, statistics, risk-based sampling, and measurement system analysis.
  • Partner with manufacturing teams to transfer products and processes into the production environment with high quality and support these products within the production environment.
  • Assess the need for any escalations for identified quality issues and assist the team members in performing escalation assessments and driving necessary corrective and preventive actions, as appropriate.
  • Run and functionally manage the Quality Engineering group; assesses skills, performs gap assessment, prioritizes team/skill development; drives talent acquisition and budgeting activities.
  • Responsible for departmental and team member goal setting, goal tracking, correcting, and rewarding, 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:
  • Setting data-driven priorities for continuous improvement of Intuitive's products and processes.
  • Ensuring quality/reliability/safety is built into Intuitive's product design by partnering with Design Engineering, Manufacturing Engineering, and Supplier Quality.
  • Ensuring data quality, process quality for anything that affects Intuitive's product or patient outcome, including the improvement of SOPs, DOPs, etc.
  • Generating risk assessments for product in the field, including recall assessment (with Regulatory Compliance)
  • Supporting deep technical failure analysis, root cause analysis, resolution, and prevention for challenging quality issues.
Qualifications

Skills, Experience, Education, & Training:
  • Good understanding of medical device company manufacturing operations and risk-based approaches to quality
  • Education: Engineering or Physics with master's degree or equivalent experience
  • Minimum 8 or more year's experience, with minimum 5 years in the quality arena working on a complex medical device product, or equivalent quality background; minimum 1-3 years of experience as a people manager.
  • Impeccable integrity and high capacity; desire to make work fun together
  • Proven ability to build, support and manage teams and to project-manage cross-functionally
  • Proven analytic skills as proven by track record for analyzing and fixing complex problems in products and processes
  • Training or commensurate experience in the science of quality
  • Proven ability to drive and motivate across functional boundaries
  • Proven ability to manage through conflicting requirements and make difficult trade-offs when resources are scarce.
  • A passion for doing the vital thing, efficiently and well
  • Excellent judgment in the presence of contesting priorities and incomplete data
  • 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.

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.