Biosafety Development Engineer

6 days ago


Sunnyvale, California, United States Intuitive Surgical Full time
Job Description

Primary Function of Position

Intuitive Surgical designs and manufactures pioneering medical devices for use in surgery. These devices consist of surgical instruments, endoscopes, diagnostic tools and accessories used on a robotic surgical platform. Each patient-contact device is evaluated for biological safety according to relevant international standards. The Biological Safety Group at Intuitive are responsible for the definition, implementation and communication of our biological safety program under the guidance of board-certified toxicologists.

The Biosafety Development Engineer is responsible for managing, collaborating with teams in support of the biological safety evaluation process for new products and changes to existing products. The successful candidate must excel in a high-energy, small-focused team environment, be a quick learner and have a commitment to high product quality. A strong sense of shared responsibility and shared reward is required and the ability to make work fun and interesting. Supporting you will be a technical services management team that knows and cares about what you are doing and wants you to succeed.

Roles and Responsibilities

  • Work closely with toxicologist and other specialists in supporting and implementing the biological safety program at Intuitive; collaborate with biosafety group members in developing safety assessment plans
  • Serve as the biological safety member to new product development teams; attend meetings, communicate schedules, present at design reviews and be responsible for peer interactions with engineering
  • Support sustaining/supplier engineering programs in gathering information on design changes for patient-contact materials and coordinating the execution of biological safety assessment plans
  • Create and maintain project management tools to track biological safety activities and be able to communicate progress on commitments to project leaders and business unit executives
  • Coordinate chemical characterization and biocompatibility testing activities at CRO laboratories in support of biosafety plans; understand testing needs, request quotes, coordinate test articles and track schedules
  • Support the creation and archival of documentation that supports the biological safety of Intuitive products; write reports, release in document management system (Agile)
  • Maintain ISI biological safety material database; provide computer generated reports as needed
  • Support engineering teams in the selection of patient-contact materials based on previous use and support the description of design, material, process and supplier changes to be evaluated for impact to biosafety
  • Support regulatory filing activities including FDA 510(k) submissions (and other filing strategies), OUS country registration activities, MDR compliance certification and other regulatory support needs
  • Develop a working understanding of medical device biocompatibility including relevant national and international standards, methods for biosafety end-point testing and other regulatory requirements


  • Sunnyvale, California, United States Danaher Full time

    EGO Program Management InternAbout Cepheid:At Cepheid, we are passionate about improving health care through faster, more accurate molecular diagnostic tests. Our innovative products are increasing opportunities to improve patient survival and quality of life, by enabling medical providers to identify and manage diseases early. Our mission is to deliver a...


  • Sunnyvale, California, United States Danaher Full time

    EGO Program Management InternAbout Cepheid:At Cepheid, we are passionate about improving health care through faster, more accurate molecular diagnostic tests. Our innovative products are increasing opportunities to improve patient survival and quality of life, by enabling medical providers to identify and manage diseases early. Our mission is to deliver a...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Intuitive Surgical, Inc. produces the da Vinci Surgical System, a minimally invasive robotic surgery system that uses highly complex mechanics, replaceable instruments and accessories, and enhanced three-dimensional visualization to extend surgical technique and precision beyond the limits of the human hand. The...


  • Sunnyvale, California, United States Apple Full time

    Imagine what you can do here. Apple is a place where extraordinary people gather to do their lives best work. Together we create products and experiences people once couldnt have imagined, and now, cant imagine living without. Its the diversity of Development Engineer, Application, Software, Development, Engineer, Technology, Benefits


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.The Automation, Equipment and Test (AET) Team is responsible for making the robots that make the robots....


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.The Automation, Equipment and Test (AET) Team is responsible for making the robots that make the robots....


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionPrimary Function of Position:Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.The Automation, Equipment and Test (AET) Team is responsible for making the robots that make the robots....


  • Sunnyvale, California, United States Amazon Full time

    Software Development Engineer, DevicesJob ID: | Services LLCDESCRIPTIONAmazon Devices is building products to enable new forms of ambient computing, and we are looking for skilled and passionate software engineers to join our world-class, growing team.As an Software Development Engineer, you will conceive, design, and bring to market computer vision...


  • Sunnyvale, California, United States Amazon Full time

    Job ID: | Services LLCAmazon Lab126 is an inventive research and development company that designs and engineers high-profile devices like the Kindle family of products. Lab126 began in 2004 as a subsidiary of , Inc. Since then, we have worked to produce best-selling e-readers and tablets, as well as new inventions like Fire TV and the category-defining...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionIntuitive Surgical, Inc. produces the da Vinci Surgical System, a minimally invasive robotic surgery system that uses highly complex mechanics, replaceable instruments and accessories, and enhanced three-dimensional visualization to extend surgical technique and precision beyond the limits of the human hand. The Software Engineer will develop...


  • Sunnyvale, California, United States Intuitive Surgical Full time

    Job DescriptionIntuitive Surgical, Inc. produces the da Vinci Surgical System, a minimally invasive robotic surgery system that uses highly complex mechanics, replaceable instruments and accessories, and enhanced three-dimensional visualization to extend surgical technique and precision beyond the limits of the human hand. The Software Engineer will develop...


  • Sunnyvale, California, United States Veear Full time

    Job Title:Hardware Infrastructure Development EngineerJob location:Sunnyvale, CAWorkplace type:HybridEmployment type:12+ Months ContractJob Description:As a Senior Software Engineer V contributing to the Hardware Testing Infrastructure team, we are seeking a pivotal individual in shaping the testing strategy, building essential resources, and fostering a...


  • Sunnyvale, California, United States Mercedes-Benz Research & Development North America Full time

    Embedded in a worldwide network Mercedes-Benz Research & Development North America continuously strives to remain at the forefront of successful automotive research and development. MBRDNA is headquartered in Silicon Valley, California, with key areas of Autonomous Driving, Advanced Interaction Design, Digital User Experience, Machine Learning, Customer...


  • Sunnyvale, California, United States IntelliPro Group Inc. Full time

    Job Title: Development EngineerPosition Type: 6 Month ContractLocation: Fully Remote (Anywhere in the USA)Salary Rate: $80 - $85/hr. on w2Job ID#: 139591Job Summary (Responsibilities and Requirements): ResponsibilitiesProvide leadership, vision, and architecture design for the front and back end of an internal platform's portal that is used across multiple...


  • Sunnyvale, California, United States IntelliPro Group Inc. Full time

    Job Title: Development EngineerPosition Type: 6 Month ContractLocation: Fully Remote (Anywhere in the USA)Salary Rate: $80 - $85/hr. on w2Job ID#: 139591Job Summary (Responsibilities and Requirements): ResponsibilitiesProvide leadership, vision, and architecture design for the front and back end of an internal platform's portal that is used across multiple...


  • Sunnyvale, California, United States Mercedes-Benz Research & Development North America Full time

    Embedded in a worldwide network Mercedes-Benz Research & Development North America continuously strives to remain at the forefront of successful automotive research and development. MBRDNA is headquartered in Silicon Valley, California, with key areas of Autonomous Driving, Advanced Interaction Design, Digital User Experience, Machine Learning, Customer...


  • Sunnyvale, California, United States Apple Full time

    Pixel Development Engineer - RGB and Depth Sensors Sunnyvale,California,United States Hardware Do you love taking on big challenges that require exceptionally creative solutions? Do you deeply understand how an incredible camera experience should work? As part of our Camera Technologies group, youll help design the innovative technology that allows each...


  • Sunnyvale, California, United States Mygwork - Lgbtq+ Professionals & Allies Full time

    As a Software Development Engineer in Sidewalk MCU team you will be responsible to design, develop, maintain the features of Sidewalk MCU SDK for Sidewalk gateways and end points. An Ideal candidate would be passionate about building IOT products. You must be responsive, flexible, and able to succeed within an open collaborative peer environment. You will...


  • Sunnyvale, California, United States Infinera Full time

    CA Pay Range (Annual): At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company's incentive...


  • Sunnyvale, California, United States TalentBurst Full time

    Front End Engineer IV Location: 1) Sunnyvale, CA 2) Alpharetta, GA 3) Marietta, GA 4) Berkeley Heights, NJ Onsite 5 days a week 6+ months contract US Citizen and Green Card only The manager needs senior/experienced person who has been doing Frontend work for a while. Responsibilities:Perform requirement analysis by collaborating with business and IT...