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Senior Quality Engineer
3 months ago
Company DescriptionAt 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 DescriptionPrimary Function of Position:As Intuitive’s da Vinci Surgical System becomes adopted by an increasing population of hospitals, surgeons, and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.Intuitive seeks a strong technical contributor to support product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. This person will provide expertise and guidance to the team on Design Controls, Risk Management, Software Development Life Cycle, and Design for Reliability and Manufacturing. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements.The ideal candidate possesses a broad base of experience and a high level of technical depth and technical leadership as we develop standard practices of our organization. You will not abide “process red tape”, instead passionately seek 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, design for quality, manufacturability, and reliability methods.Position Details:The position is a Senior Quality Engineer to be in Sunnyvale, California and will interface and support Single Port business unit.Roles and Responsibilities:Contribute to the product development efforts on software and hardware projects, primarily responsible for overseeing the execution and review of design controls, process controls, risk management, and SDLC deliverables.Working knowledge of Design Controls, Risk Management, and Software Development Lifecycle Process; review and provide quality and compliance input to project teams for project decisions and associated deliverables (i.e. Design Inputs, Design Outputs, Design Reviews, Design V&V, Usability Testing, SW Validation, Design Transfer, Process Validation and Labeling).Support the development of product design history file and ensure compliance to internal processes and external standards and regulations.Partner with engineering to define design inputs, design outputs, and traceability matrices.Creation of Risk Management Plans and Reports and contribute to the creation and review of Top-down and bottom-up risk analysis by collaborating cross-functional.Understand and support linkage of post market and production and process controls data to the elements of Risk Management and Design ControlsApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).Provide quality leadership for new products and sustaining development teams and support the review ofEnsure appropriate translation of user needs into design inputs while ensuring compliance to applicable standards and regulations.Support the development of product design history file and ensure compliance to internal processes and external standards and regulations.Partner with engineering to define design inputs, design outputs, and traceability matrices.Contribute to the strategy and execution of risk-based design verification and validation.Participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier.Ensure reliable and scalable designs to transferred to manufacturingReview design architectures, selections, requirements, and drawings from early designCollaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production.Assist in supplier selection, qualification, certification, and performance improvement.Contribute to new product development Technical Reviews and Design Reviews.Support Regulatory Affairs with creating submissions and responding to submission questions.Support internal and external audits, including preparation and direct interaction with auditors.QualificationsSkills, Experience, Education, & Training:Education: Minimum Bachelor’s degree in electrical, mechanical or system engineering, math, or physics.Minimum 8+ years of working experience in Quality Engineering, minimum 4 years in electromechanical systems and software design and development within the Medical Device Industry.Solid understanding of design control and risk management from early design and development through commercializationDemonstrated experience with electromechanical system (including software) from concept through launch is required.Experience with medical standards compliance, including ISO 13485, ISO 14971, ISO 62304, ISO 60601, IEC 62366, and FDA Quality System Regulations with a focus on design controls and design optimization.Able to navigate quality system with minimal oversight on personal projects.Balanced risk decision making to drive product quality, gain consensus, and work through technical challenges.Solves complex problem with minimal oversight.Able to articulate complex information to teams, including executive management.Additional InformationDue 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.SummaryType: Full-timeFunction: ManufacturingExperience level: AssociateIndustry: Medical Device
