Intuitive
Quality Engineering Manager - Multiport Da Vinci (I&A)
Intuitive, Sunnyvale, California, United States, 94087
Quality Engineering Manager - Multiport Da Vinci (I&A) – Intuitive
Join to apply for the Quality Engineering Manager - Multiport Da Vinci (I&A) role at Intuitive. This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $132,600.00/yr - $224,400.00/yr 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. 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. Job Description Primary Function of Position: This person manages the Quality Engineering group within the Endoluminal Business Unit and is responsible for maintaining and advocating product quality, leading an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission. Essential Job Duties Leads New Product Introduction and Sustaining for DaVinci Instruments and Accessories, 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 decisions. 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. Lead and functionally manage the Quality Engineering group; assesses skills, performs gap assessment, prioritizes team/skill development; leads talent acquisition and budgeting activities. Responsible for departmental and individual 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 Required Skills and Experience Good understanding of medical device company manufacturing operations and risk-based approaches to quality Proven ability to build and manage teams and to project-manage cross-functionally Strong 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 lead 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 competing priorities and incomplete data Travel requirement for this position is 10% Required Education and Training Education: BS in Engineering (master’s degree preferred) or equivalent experience; 8 or more years of experience, with 5 years in the quality arena working on a complex medical device product, or equivalent quality background; 1-3 years of experience as a people manager. Additional Information Due to the nature of our business and the role, Intuitive and/or your customer may require you to show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal 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. Mandatory Notices: 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 certain states. We provide market-competitive compensation packages, including base pay, incentives, benefits, and equity. The base salary ranges are Region 1: $156,000 - $224,400 and Region 2: $132,600 - $190,800. Shift: Day. Workplace Type: Set Schedule - onsite weekly; percentage onsite defined by the leader. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance Industries Medical Equipment Manufacturing
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Join to apply for the Quality Engineering Manager - Multiport Da Vinci (I&A) role at Intuitive. This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $132,600.00/yr - $224,400.00/yr 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. 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. Job Description Primary Function of Position: This person manages the Quality Engineering group within the Endoluminal Business Unit and is responsible for maintaining and advocating product quality, leading an organization that is equipped to reach across the company acting as emissaries for the Product Quality mission. Essential Job Duties Leads New Product Introduction and Sustaining for DaVinci Instruments and Accessories, 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 decisions. 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. Lead and functionally manage the Quality Engineering group; assesses skills, performs gap assessment, prioritizes team/skill development; leads talent acquisition and budgeting activities. Responsible for departmental and individual 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 Required Skills and Experience Good understanding of medical device company manufacturing operations and risk-based approaches to quality Proven ability to build and manage teams and to project-manage cross-functionally Strong 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 lead 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 competing priorities and incomplete data Travel requirement for this position is 10% Required Education and Training Education: BS in Engineering (master’s degree preferred) or equivalent experience; 8 or more years of experience, with 5 years in the quality arena working on a complex medical device product, or equivalent quality background; 1-3 years of experience as a people manager. Additional Information Due to the nature of our business and the role, Intuitive and/or your customer may require you to show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal 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. Mandatory Notices: 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 certain states. We provide market-competitive compensation packages, including base pay, incentives, benefits, and equity. The base salary ranges are Region 1: $156,000 - $224,400 and Region 2: $132,600 - $190,800. Shift: Day. Workplace Type: Set Schedule - onsite weekly; percentage onsite defined by the leader. Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance Industries Medical Equipment Manufacturing
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