Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200560
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and
decreasing surgical invasiveness, with patient safety as our highest priority
Primary Function of Position:
This person leads and functionally manages a group of Quality Engineers focused on servicing of products classified as Systems and/or Vision. He or she interfaces with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical. While this team of Quality Engineers is primarily focused on products produced and sustained by the Service & Secondary Markets business unit, Quality Engineering also leads and/or supports Product Quality; Data Quality; Process Quality; Corrective Action Preventive Action (CAPA); Lessons Learned; Solutions to challenging quality problems; Organizational input to our Quality Review Board; Organization of Enterprise data for quality; and 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 products to market quickly, continuously improve it, and rapidly fix problems.
• Working in close cooperation, sharing a common 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, Service and Secondary Markets is primarily responsible for:
o Developing and maintaining a partnership with product design teams to ensure new products are of high quality, have compliant documentation with regard to risk and mitigation of such, and are compatible with on-going quality assurance activities.o Development of Master Validation Plans for new facilities and products which include the identification of components and processes that require specific attention to assure the quality of the over-all products and the methods for applying that attention including the generation and/or oversight of the following:
Applicable DOPs and SOPs Design Risk: FMEA, , design V&V Process Risk: Process FMEA, Supplier Process FMEA, in-house Process V&V, supplier process V&V, EFT Qualifications, Line qualifications Generation of Quality Assurance processes for forward production including drawing reviews, incoming inspection plans, Quality Assurance Plans (QAPs), and Final Quality Inspection (IFQI) procedures.
o Generation and review of change orders that release documentation of quality operations described above.o Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports).o Project-managing a distributed, lower-level Continuous Improvement process.o Communicating Lessons Learned to design teams, supplier-facing teams, etc.o Ensuring that risk estimation is done well at all levels of the organization (Risk Assessment, Failure Mode Evaluations, Process Risk Assessments).
• Quality Engineering is a stakeholder and shares responsibility for:
Qualificationso Setting data-driven priorities for continuous improvement of ISI products and processes.o Ensuring quality/reliability/safety is built into ISI designs; coordinating with Design Engineering, Manufacturing Engineering, and Supplier Quality.o Ensuring data quality, process quality for anything that affects ISI product or patient outcome, including the improvement of SOPs, DOPs, etc.o Generating risk assessments for product in the field, including recall assessment (with Regulatory Compliance)o Supporting deep technical failure analysis, root cause analysis, resolution, and prevention for challenging quality issues.
Skills, Experience, Education, & Training:
Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
• Impeccable integrity• Proven ability to lead and motivate across functional boundaries• Good understanding of medical device company manufacturing operations, CAPA systems, and risk-based approaches to quality• Education: Engineering or Physics with Bachelors Degree or equivalent experience• Engineering or Engineering Management background; strong electromechanical underpinnings.• Five or more years’ experience in the quality arena with a complex medical device product, or equivalent quality background• Ability 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.• 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, matched with real-world experience (Lean, Six-Sigma, Deming, Toyota, etc.)• Proficiency across the Microsoft Office suite of productivity software• Excellent judgment in the presence of competing priorities and incomplete data; proven ability to make difficult trade-offs• A passion for finishing the vital thing, efficiently and well; attention to the right details• A strong desire to make work fun
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.