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Design Validation Engineer

Company: Digital Intelligence Systems, LLC
Location: Sunnyvale
Posted on: March 27, 2020

Job Description:

Job Title Design Validation Engineer Location Sunnyvale, CA Duration 12+ Months 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 The Design Validation Engineer plays a vital role in developing safe and effective medical devices. As an embedded member of the Digital Data Development (D3) team, they will manageconduct software validation deliverables in support of software applications within the D3 organization. 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 (DHFs) meet all regulatory requirements. The Design Validation Engineer is expected to bring to their role a passion for proper design control methodology, a strong sense of pride in their work output, and a real interest in technology, products, and application. Position Roles and Responsibilities Responsibilities Use traceability database software tools extensively to manage design control and SDLC documents and the links between document content. Extensive data entry and management will be required. Assist the D3 team with compiling and updating engineering design control documents for Design History Files, including risk analyses, requirements, tracing and design verification and validation test documentation. Use change control management system (Agile) to release and update controlled documents, route Engineering Change Orders, maintain Design History Files. As an embedded core team member, work with core team to outline all product validation and design control deliverables for projects Support validation projects for new applications as well as change control of existing applications. Train D3 organization to software validation requirements (Procedures Standards Best Practices). Support design team to produce high quality, consistent design documents that meet requirements. Coordinate with other departments as necessary in order to assure that product documentation (including user manuals, labeling, and training) is consistent with design documentation. Manage software change control and defect tracking. SkillsExperience Minimal Requirements Bachelorrsquos Degree in engineering, other technical area or business administration preferred Excellent technical writing and communication skills Strong attention to detail to minimize documentation errors Ability to understand complex technical information and translate into writing In-depth understanding of design control best practices and GxP A minimum 3 yearrsquos work experience with Design Control or Validation focus within the Medical Device andor Pharmaceutical Industries is required. Experience writing and reviewing engineering complex technical information and translate (design control) documents, including specifications, test protocols and test reports Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs) Ability to manage challenging assignments and multiple assignments in parallel Assertive, outgoing personality with an ability to work collaboratively within an engineering team Skilled in the use of Microsoft Office Suite Strong data entry skills Ability to multi-task and work independently with minimal supervision Understanding of design control and SDLC concepts Skilled in the use of Agile (or similar lifecycle management system tool), PTC Integrity, Polarion, DOORS, or other requirements management (ALM) tool Experience with ISO 13485, ISO 14971, ISO 80002, IEC 62304, 21 CFR Part 11, 21 CFR 820 and FDA GMPs. Thanks, Karan Sharma Senior Technical Recruiter Digital Intelligence Systems, LLC (DISYS) (o) 630-748-8613 www.disys.com httpwww.disys.com Email Id Karan.SharmaDISYS.COM mailtoKaran.SharmaDISYS.COM

Keywords: Digital Intelligence Systems, LLC, Sunnyvale , Design Validation Engineer, IT / Software / Systems , Sunnyvale, California

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