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Sunnyvale, California, United States Intuitive Surgical Full timeJob SummaryIntuitive Surgical is seeking a highly skilled Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for ensuring the quality and safety of our medical devices, specifically in the areas of sterilization and reprocessing.Key ResponsibilitiesDevelop and implement quality control procedures for sterilization...
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Senior Quality Engineer, Sterilization and Reprocessing
4 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:Intuitive designs and manufactures highly complex systems for use in robotic-assisted surgery and minimally invasive lung biopsy. These systems employ a combination of reusable and single-use devices for each procedure. The primary function of the Senior Validation Engineer is to act as a central company resource for cleaning, disinfection, and sterilization testing and validation of reusable devices. This person will work with cross-functional teams to provide design inputs that enable effective cleaning, disinfection, and sterilization of new reusable medical devices. The Senior Validation Engineer will conduct cleaning, disinfection, and sterilization validation testing on-site or in cooperation with external laboratories to support domestic and international regulatory submissions. This person must have a good working knowledge of domestic and international standards related to reprocessing. This role may include interaction with final users to understand central reprocessing procedures, help streamline workflows, and improve instructions for use.The successful candidate must excel in a high-energy, high capacity, and fast-paced environment working with multidisciplinary teams to drive solutions from early design requirements to product launch and support. Essential to this role is a high commitment to product quality and the ability to learn rapidly and create innovative solutions. A sound sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting. Supporting this role is a management team that is invested in what you do and wants you to succeed.Roles and Responsibilities•Drive multiple validation and verification studies including cleaning, disinfection, and sterilization involving rigorous data analysis with focus on the safety and efficacy of new robotic medical devices.•Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (vendors and laboratories).•Define reprocessing test approach and test plans to ensure safety and efficacy for new instrument and accessory products across the company's product platforms. Provide subject matter pro input for design, materials, and product requirements for optimized reprocessing output.•Collaborate with Regulatory Affairs to support domestic and international regulatory submissions and approvals•Develop and maintain procedures and best practices to ensure compliance with applicable domestic and international cleaning, disinfection, and sterilization standards.•Optimize cleaning, disinfection, and sterilization control processes, systems, and procedures.•Support development of harmonized reprocessing manuals for end users, minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices.•Good working knowledge of medical device industry standards and guidance for medical device reprocessing.•Support field visits to central reprocessing customer sites and make recommendations for improvements to streamline reprocessing workflows•Participate in AAMI working groups in the development of new standards in this field•Other duties as assignedQualificationsSkill/Job RequirementsAptitude is based on: education, training, skills, and experience. To adequately perform the responsibilities of this position the team member must have:•BS in Engineering, Life Science, Microbiology or technical equivalent; Masters is preferred•Minimum 8 years of professional experience in the medical device field, with at least 3 years in:Medical device cleaning validation experienceMedical device sterilization validation experience (may include steam, EO, gamma, e-beam, and low- temperature modalities)Flexible endoscope cleaning, disinfection, and sterilization validation experience•Familiarity with US and international medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, AAMI ST98, AAMI ST91, ISO 15883, ISO 11135, ISO 11137, AAMI TIR 28.•Top person verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents.•Self-starter with ability to steer in a fast-paced environment.•Able to prioritize and manage multiple projects and focus execution•Hands-on experience with proven ability to work well in cross-functional team environment and meet project goals•Attention to detail along with flexibility to support various projects•Well versed in MS Office Suite including statistical examination tools.•Ability to travel to customer or laboratory sites (10%), including international travel.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.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.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.
