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Manager Quality Engineering

3 months ago

Sunnyvale, United States Intuitive Surgical Full time

Company DescriptionAt 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 DescriptionPrimary Function of Position: This person leads and functionally manages the Quality Engineering group. You will interface with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical. Quality Engineering is primarily responsible for measuring quality and helping the company apply those data quickly, intelligently and consistently. Quality Engineering is broadly responsible for or a stake-holder in Product Quality; Data Quality; Process Quality; Corrective Action Preventive Action (CAPA); Lessons Learned; Solutions to challenging quality problems; Design for Quality in new product; Organizational input to our Quality Review Board; Organization of Enterprise data for quality; Functional specification of Quality enterprise software.Roles & Responsibilities:Being a proponent of Product Quality throughout the organization; including the ability to work pragmatically and cooperatively with leaders throughout the company to deliver high-quality product to market quickly, continuously improve it, and rapidly fix problems.Working in close cooperation, with a shared vision, with leadership from Quality Assurance, Supplier Quality, Incoming Quality Control, Business Analytics, and others, and communicating throughout the organization.Leading and functionally managing the Quality Engineering group (skills and gap assessment, talent acquisition, and development).Quality Engineering is primarily responsible for:Organizing sources and internal customers for quality data; identifying ways across the enterprise to close quality loops more quickly. Structuring needed quality metrics to help others measure themselves and assess the cost of quality appropriately. Facilitating the use of good tools and techniques overall.Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports).Owning the Nonconformance and CAPA systems, leading teams that monitor quality data, ensuring that analyses and documentation meet standards.Facilitating weekly product quality meetings and driving high performing teams to focus on product quality enhancements.Running periodic Quality Data review meetings and cross functionally to addressneeds.Ensuring that risk estimation is done well at all levels of the organization (Risk Assessment, Failure Mode Evaluations, Process Risk Assessments, Health Hazard Analyses).Communicating Lessons Learned to design teams, supplier-facing teams, etc.Project-managing Continuous Improvement projects.Quality Engineering is a stakeholder and shares responsibility for:Setting data-driven priorities for continuous improvement of ISI products and processes.Ensuring quality/reliability/safety is built into ISI designs, while coordinating with Design Engineering, Manufacturing Engineering, and Supplier Quality.Ensuring adequate design control throughout the product life cycle and Quality Engineering deliverables are met.Ensuring data quality, process quality for anything that affects ISI 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.QualificationsSkills, Experience, Education, & Training:Must HaveMinimum 5+ years’ experience in the quality arena with a complex medical device product, or equivalent quality backgroundMinimum 3+ years' experience as a manager in the quality arenaEducation: Minimum Engineering or Physics with Masters Degree or equivalent experienceMinimum 3+ years medical device company experience within engineering or quality (preferably) manufacturing operations, CAPA systems, and risk-based approaches to qualityPreferredPrior experiences in optical/vision components/subassemblies (i.e. endoscopes and vision systems) and the associated capital equipment are preferred.Impeccable integrityProven ability to drive and motivate across functional teamsEngineering or Engineering Management background; proven electromechanical underpinnings preferredAbility to communicate easily with stakeholders and develop compelling vision for the QE group, and find win-win agreements with Engineering. Understand ISI’s culture of fast innovation and iterative improvement.Exceptional analytic skills as proven by track record for examiningand fixing complex problems in products and processesTraining or commensurate experience in the science of quality, matched with real-world experience (Lean, Six-Sigma, Deming, Toyota, etc.)Proficiency across the Microsoft Office suite of productivity softwareExcellent judgment in the presence of contending priorities and incomplete data; proven ability to make difficult trade-offsA passion for finishing the vital thing, efficiently and well; attention to the right detailsA desire to make work funAdditional InformationDue 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.SummaryType: Full-timeFunction: OtherExperience level: DirectorIndustry: Medical Device