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Design Controls Systems Engineer

Company: Maxonic, Inc.
Location: Sunnyvale
Posted on: February 15, 2020

Job Description:

Job Title: " Design Controls Systems Engineer" Employment Type: Contract Location: US Sunnyvale, CA Duration: 6 months+ Job Description: 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. Primary Function of Position: We are seeking a Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and processes. The Design Controls Systems Engineer will help develop, verify, and deploy new tools in compliance with established Design Control, Quality, and IT processes. The ideal candidate is quality focused with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time. The candidate has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools. The position includes: Working with cross functional teams to solve problems and execute improved tools and processes Assisting in authoring and ECO release of documents needed to support additional functionality in ALM tool (test execution and migration of content) Test case development, execution, and documentation for computer software verification. Skill/Job Requirements: Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971) Requirements Management excellence including how to translate technical details into unambiguous, testable, reusable requirements and specifications Strong communicator and relationship builder Detail-oriented and Quality-focused Excellent investigative skills Qualifications: Bachelor s Degree preferred 5+ years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation Experience with Application Lifecycle Management tools such as Siemens Polarion, PTC Integrity, and Doors Excellent verbal and written communication skills Excellent planning and time management skills Highly proficient in Word, Excel, Visio, and PowerPoint Proficiency in Oracle/Agile helpful - provided by Dice

Keywords: Maxonic, Inc., Sunnyvale , Design Controls Systems Engineer, Other , Sunnyvale, California

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