May 16, 2022 A Technology Blog

Job Opening for Design Controls Engineer in Intuitive (3420 Central Expy, Santa Clara, CA 95051)

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Job Category : Engineering
Company Name: Intuitive
Position Name: Design Controls Engineer
Location : 3420 Central Expy, Santa Clara, CA 95051
Job Description : 5 Month contract opportunity Compensation: $70.00 – $100.00/hr Worksite: 3420 Central Expressway, Santa Clara, California, 95051 At Intuitive, 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 in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s most complex challenges. Join us in making big leaps forward for healthcare professionals and their patients. Together, let’s help to advance the world of minimally invasive care. Primary Function of Position: The Design Controls Engineer plays a vital role in developing safe and effective medical devices at Intuitive Surgical. As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHF’s) meet all regulatory requirements. The Design Controls Engineer demonstrates a strong sense of pride in their work output and a real interest in Intuitive Surgical’s technology, products, and applications. Roles & Responsibilities: Assist the new product development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation. Assist the new product development team with architecting a holistic documentation/tracing structure that is easily maintained. Support design team to produce high quality, consistent design documents that meet Intuitive Surgical’s design control processes. Use the requirements management database tool extensively to manage design control documents, and the links between document content. Activities: Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive Surgical’s design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists. Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews. Produce requirements trace mapping and associated documentation. Use PTC Integrity and/or Siemens Polarion as a tool to accomplish the following: Enter and edit documents. Create and edit requirements and test cases. Create trace links Produce reports using standard report templates. Create additional custom reports as needed. Produce trace reports. Use Agile as a tool to accomplish the following: Organize and structure Design History Files (DHF) using Design Control checklists. Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes. Work with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process. Skills, Experience, Education, & Training: Bachelor’s Degree in engineering or other technical area Ability to understand complex technical information and translate into writing Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction. Ability to manage challenging assignments and multiple assignments in parallel Strong planning, decision making, negotiating and change management skills Assertive, outgoing personality with an ability to work collaboratively within an engineering team Excellent writing and communication skills, and attention to detail Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat Preferred Skills & Experience: Experience working in an ISO 9001 medical device product development environment or other regulated industry Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports Skilled in the use of Agile or similar lifecycle management system tool Skilled in the use of Integrity, Polarion or other requirements management tool Development experience with complex systems with a combination of hardware and software Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs) Please note that this is a contract role providing services to Intuitive through our direct sourcing partner, Raise Recruiting, who manages Intuitive’s Contractor Talent Community. If you are selected for this role, you will be employed by Raise and will not be an employee of Intuitive. Work with an Award Winning Employer: Best Places to Work, Glassdoor Employees’ Choice, 2019 (#12 of 100), 2020 (#7 of 100) America’s Best Midsized Employers, Forbes, 2019 (#149 of 500) Top 150 Places to Work in Healthcare, Becker’s Hospital Review, 2019 Top CEOs, Glassdoor, 2019 (#9 of 100) Raise and Intuitive are Equal Employment Opportunity Employers. 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 all qualified applicants with arrest and conviction records in accordance with fair chance laws. Int22
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