Staff Quality Engineer, Digital and Data Software Products
Company : Intuitive
Country: United States
Location : Sunnyvale, California
Post: Mon, 01 Aug 2022 04:34:03 GMT
Expires: Wed, 31 Aug 2022 23:59:59 GMT
Apply Job : Apply Online
—————————— Job 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.
PRIMARY FUNCTION OF POSITION:
As Intuitives da Vinci Surgical System continues to be adopted by an increasing population of hospitals, surgeons and patients, we are expanding our product offering to support a more comprehensive robotic program four our customers. Part of this expansion requires the delivery of software solutions and some off-the-shelf hardware that represent a new type of Intuitive Product. The primary focus of this position to support design teams tasked with development and delivery of these products from a Product Quality perspective. Intuitive seeks a strong technical contributor who can lead cross functional teams in process development, help define practical, useful quality metrics and specifications, identify key opportunities for product and process improvement, launch quality initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve the most technically challenging quality problems.
The ideal candidate possesses a broad base of experience and a high level of technical depth in ensuring product quality during design and development of digital software medical and GxP products. You will not abide process red tape, instead passionately seeking the most efficient way to build in product quality. And you will also coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods. Help us powerfully drive our quality mission in our growing company by bringing your hands-on experience in solving tough engineering problems in a compliant way, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.
ROLES & RESPONSIBILITIES:
o Run complex problem-solving efforts without oversight, and mentor others on best practices. Use advanced Six Sigma tools. Introduce and drive the adoption of new tools and methods to the business. Apply strong analytic skills as proven by track record of analyzing and fixing complex problems.
o Advise others on best practices in quality controls for software centric products. Understand Design Controls, Change Controls, Product Engineering processes, SDLC, and Production process control methodologies in a medical device environment. Author Master Validation Plan (MVP), Master Validation Report (MVR), Device performance summary report and procedure deviations.
QUALITY SYSTEMS & RISK MANAGEMENT
o Participate in ongoing implementation of the Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design controls, as well as SDLC processes and tool initiatives. Navigates quality system independent of oversight. Makes updates to improve quality systems and mentor others. Analyzes RMAs, QNs and make the necessary updates to risk documents. Guides software development teams on product and cybersecurity Risk management activities.
o Solid knowledge of industry standards related to computerized systems and electronic record/signature, 21CFR Part 11, Annex 11, GAMP5.
o Able to articulate the latest and complex regulation to project team. Able to understand the impact of regulations to our procedures and make the corresponding SOP/DOP updates. Able to contribute to external audits, perform internal audits.
ABILITY TO INFLUENCE OTHERS
o Passionate about our mission to improve product quality. Able to use persuasive, logical arguments based on data. Assist people in finding creative compliant solutions which meet constraints. Lead by example.
A passion for doing the vital few things efficiently and well
A strong desire to make work fun
Additional responsibilities as assigned
SKILLS, EXPERIENCE, EDUCATION, & TRAINING:
* Minimum Education- 4-year degree in software, Biomedical, electrical, mechanical or system engineering, math, or physics. Software focus is preferred. Advanced degree is also preferred.
* Technical Expertise: At least two areas of deep technical expertise applicable to the manufacture of medical robotic systems, one of which must be SOFTWARE CENTRIC. A minimum of 8+years experience in one of these disciplines.
* Example areas of expertise:
* Medical device software development, software quality best practices
* Quality science and quality management
* Quality statistics
* Controls, algorithm development
* Mechanical engineering, with experience relevant to robotic systems
* Electrical engineering, with experience relevant to robotic systems
* Design for reliability, manufacturability, serviceability
* Experience in training, working collaboratively with software development teams.
* Experience with digital health or digital IT.
* Experience working on low and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
* Excellent organizational, interpersonal and verbal and written communication skills, with the ability to deliver quality outputs under minimum supervision.
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.
SHIFT : Day
TRAVEL : 10% of the time
Travel Requirements:10% of the time Shift:Day
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