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 and grows a Quality Engineering team that is equipped to reach across the company acting as representatives for the Product Quality mission. This person will focus on single-use and multi-use robotic surgical instruments and accessories.
The Intuitive Quality Engineering is responsible for developing quality metrics and helping the company apply them intelligently and consistently.Quality Engineering is broadly responsible for, or a stake-holder in Product Quality; Data Quality; Process Quality; Solutions to challenging quality problems; Design for Quality in the new product; Organizational input to QRB; Organization of Enterprise data for quality.
The Quality Engineering Manager is responsible for managing the team of Quality Engineers, evaluating their results and further develop the team members. He or she interfaces with leaders including VPs and Directors throughout the design, operations, regulatory, IT, marketing and service areas of Intuitive Surgical.
Roles & Responsibilities:
This position has responsibility and authority for:
Manage group of Quality Engineers and support them through their day to day responsibilities
Oversees the preparation of the Quality metrics presentations for QDR / QOR Meetings and analyzes the data to obtain conclusions to define proper action plans for continuous improvement
Assess issues and Escalates based on criticality.
Liaison with other Quality functions representatives in other Intuitive locations and with other company functions as it applies.
Represents the Quality Engineering function in projects of medium to high complexity, Escalation Processes, CAPA's, External and Internal audits.
Defines the Quality Engineering organizational structure to provide the required support.
Anticipates future needs in order to adequate the organizational structure according to company growth/changes.
Identifies opportunities for improvements in Product Quality, Processes Efficiency, Cost Reduction, and coordinates the team of QE's for the implementation of these opportunities to achieve our company goals.
Defines and executes the development plans for the Quality Engineering team under her or his responsibility, establishing and documenting development goals and tracking its progress.
Serving and proponent for quality across the enterprise
Providing metrics and guidelines to functions to assist in trending and improving quality
Applying metrics to measure quality and metrics to trade quality off against other attributes of a successful enterprise ("cost of quality")
Maintaining a prioritized list of quality initiatives on three levels
Product quality - Analysis of product failures and reliability opportunities; metrics; deep failure analysis; assistance in project management of projects that address said failures; metrics of improvement
Data quality - Understanding and analysis of how the enterprise acquires and processes raw data to derive action priorities and plans; development of data quality vision and negotiation for the gradual adoption of that vision throughout the enterprise. This requires an understanding of how IT and Operations manage and input quality data, as well as cost-benefit trade-offs for potentially costly "perfect data".
Process Quality - analysis of processes that affect product quality, or guidance to others to analyze their processes.
Project management help for a series of Product, Compliance, and Quality projects.
Supporting New Product Introduction initiatives by assessing Quality Engineering resources needed and allocation.
Support for deep technical failure analysis and analysis of challenging quality issues
Generation of input for QRB, including managing the quality of other organizations' input.
Review of quality data collected regularly and setting of priorities, such as Bioburden / Endotoxins and CER performance data trending analysis review and reporting.
Gathering and making available to enterprise customers a routine set of quality data for their weekly use (standard quality reports)
Revision and approval of internal documentation, including:
Work instructions (MPI's, IVI's, QAP's, Acceptance criteria, etc.)
Operating procedures (SOP's, DOP's, etc.)
Validations (IQ, OQ, PQ, PPQ)
Take responsibility for developing and maintaining compliance with the quality system.
Review and assign priorities to Quality Engineers when production line support is required.
Support on the implementation of assembly lines or product transfers into our facilities, including planning, validation/verification and final implementation.
Drive our Culture Strategy by fostering our mission, founding principles, individual and leadership expectations.
Qualifications Skills:
Competency Requirements: (Competency is based on: education, training, skills and experience.) In order to adequately perform the responsibilities of this position the individual must possess:
Required:
Impeccable integrity
Education: Minimum BS in Engineering degree (Master degree is preferred) or equivalent experience
Minimum 5 years experience in the quality arena of medical device manufacturing, or equivalent quality background, experience in complex electro-mechanical devices and single-use devices is preferred.
Proven ability to build and manage teams and to project-manage cross-functionally
Minimum 2 years experience managing groups of professionals.
Strong analytic skills as proven by track record for analyzing and fixing complex problems in products and processes
Demonstrate strong leadership skills to coordinate and coach reporting engineers.
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
Possess strong communication skills to interact with suppliers, other departments within the company (Supplier Engineering, New Product Introduction, Planning, Purchasing, Regulatory, Product Quality, etc., in Sunnyvale)
Preferred:
Minimum MS in an engineering discipline.
Lean Six Sigma training.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits and equity, and the anticipated pay rate for this position is $145,300 to $209,100. 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 location, skills, and experience level. 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.
