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Applications Engineer

3 months ago

Sunnyvale CA, United States Intuitive Surgical Full time

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 PositionWe are seeking an engineer to support the Intuitive Surgical team focused on new product development tools and process. The engineer in this position will help develop, verify, and deploy new engineering tools (for internal use) and processes in compliance with established Design Control DOPs and associated processes. The ideal candidate is a quality focused self-starter with excellent problem-solving skills, a keen attention to detail and a passion for software architectures and processes. The candidate must have a functional understanding of Medical Device regulations and experience implementing compliant requirements management or test management processes and automation tools.Essential Job DutiesSupport validation testing of Design Control Tools and Processes by following testing strategy and writing test cases to ensure design requirements are met.Design and implement UI features and ancillary scripts using Python, JavaScript, SQL and VelocityTest and debug scripts, queries, dashboards, and reports from toolsWork with cross-functional teams to identify pain points, inefficiencies, and potential areas of design control gaps.Collaborate with business stakeholders to understand requirements and translate them into solutions to deliver approved tools and process improvements/optimizations.Enterprise-wide tools development, verification, support, and training.Configuration, maintenance, and administration of corporate Design Controls tools and data content.Develop tools, templates and optimized workflows that improve product development productivity.Support compliance with global medical device deliverables including submissions and DHFs.Develop and assist in delivery of training to help drive adoption of Design Control processes and tools across the company.User support for documentation and traceability reports for regulatory submissions.QualificationsRequired Skills and ExperienceBasic Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)Programming skills in Python, JavaScript, Velocity, SQL, and/or HTMLBasic understanding of database architecture and design strategyRequirements Management excellence to help translate technical details into unambiguous, testable, reusable requirements and specificationsUnderstanding of multiple technology areas (software, mechanical, electrical, biomedical, clinical, robotics, test automation, etc)Ability to help end users from cross functional teams to efficiently create fully documented, robust, and reliable medical devicesDetail-oriented and quality focused with excellent investigative skillsStrong communication skills with experience in training end users including developing training content and addressing user support questionsRequired Education and TrainingBachelor’s Degree in Engineering/CS related field required. Master’s degree preferred.1-3 years of previous related experience in medical device development, applications engineering, systems engineering, software development, requirements management, test management, and/or regulatory documentationExcellent verbal and written communication skillsExcellent planning and time management skillsHighly proficient in Word, Excel, Visio, and PowerPointWorking Conditions Set Schedule (on-site 3+ days per week) Preferred Skills and Experience Proficiency in Oracle/AgileExperience with using automated test execution tools such as but not limited to MF ALMExperience with using Application Lifecycle Management (ALM) Tools such as Polarion, MKS/PTC Integrity, DOORS, HP ALMAdditional specialized training in a discipline such as software engineering, test engineering, quality, risk management, or regulatory compliance.Knowledge of Part 11 compliance for electronic signature and digital recordsAdditional 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: Information TechnologyExperience level: AssociateIndustry: Medical Device