Director Quality Engineering onsite - Sunnyvale, CA, United States - Intuitive

Description

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: The Director, Quality Engineering will be a key member of the Product Quality leadership team with broad responsibilities. The person in this position will provide leadership, technical and administrative mentoring across interdepartmental boundaries as related to development and manufacturing of high quality, minimally invasive robotic surgical equipment. This key management role will be challenged to effectively lead the quality resources required to support business growth sales demand through the successful introduction of new products. Proven experience achieving results through others and managing wide range of individuals is required. Quality performance track record in a medium to large-scale medical device manufacturing, new product introduction, and scale-up is preferable. Essential Job Duties:

• Identify, investigate, properly document, and implement quality improvements and initiatives for both product and process; coach others in doing the same. Drive these issues through quality system vehicles such as CAPA, PPIR, HHA, VR, NCR, etc.
• Provide oversight, training, and direct review of the generation of quality documents and records related to implementation and/or compliance with medical regulations (i.e. CFR 820, ISO 13495, et al.)
• Creates vision, strategy, and tactics which effectively integrates multidisciplinary strategies enabling seamless execution and goal obtainment.
• Creates an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
• Lead with inclusion and build a diverse workforce that models and champions Intuitive Surgical' s culture and value setFoster an inclusive culture built around diversity of thought, collaboration and teamwork across organizational and geographical boundaries; willing to break down functional silos to optimize business results and to facilitate the overall growth of the company.
• Lead NPI facing Quality Engineering function.
• Lead NPI Quality team to define and improve reliability of new products.
• Establish and lead the COE organization for Risk Management, Design Control, and Quality Notifications.
• Build and inspire a highly motivated team by attracting, hiring, training, developing and retaining top Quality talent
• Deploy technically competent Quality Engineers and other quality professionals to provide quality-based deliverables to the Design Control process and on-going operations, including but not limited to the following: Master Validation Plans, dFMEA, pFMEA, inspection plans, critical component evaluations, product and process validations, etc.
• Ensure full participation of Quality Engineering with NPD and NPI functions.
• Ensure design compliance with applicable medical device standards.
• Create and maintain Quality Manual components under the purview of the position.
• Continuously improve product cost, quality, delivery, and service levels
• Highly skilled at translating strategic, financial and technical content into a clear sense of purpose that effectively engages multiple teams (within and outside direct span of influence).
• Develops strong and enduring relationships internally and externally through consistent use of sophisticated communications.
• Support other Quality and/or Regulatory efforts as required.

Qualifications Required Skills and Experience

• Proven experience and track record regarding process improvement of complex manufacturing systems
• Strong technical analytical skills including FMEA, statistical methods, and Six Sigma techniques
• Must be familiar with sampling procedures and tables for inspection by attributes.
• Working knowledge of Geometric Dimensioning and Tolerance and ability to read technical drawings
• Previous Medical Device manufacturing experience highly desirable
• Excellent communication skills a must
• Highly proficient in Microsoft Word, Excel, and Project programs
• Full time position, Sunnyvale, CA location preferred

Required Education and Training

• Minimum BS in engineering sciences or equivalent, advanced degree in Mechanical Engineering or Bio Medical Engineering preferred.
• Minimum 12 years' experience in medical Design, Quality, Manufacturing and/or Engineering.
• Minimum 5-7 years mid-level management experience

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. 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.
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