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This advert was matched to Mechanical Design Engineer, a job title Intuitive Surgical Operations, Inc. has itself sponsored.
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The role, as Intuitive Surgical Operations, Inc. describes it
Primary Function of Position The Design Control Engineer contributor within the Product Quality organization, responsible for
supporting the design and development of safe, effective, and compliant medical device products. The Design Controls Engineer is responsible for assisting and training Design Engineering and New Product
Introduction teams with their regulatory and quality documentation deliverables in support of Design
Control milestones and DHF maintenance. You will be responsible for direct user support in addition to
content development and training delivery for Design Controls tools. As process and tools experts, the
Design Controls Engineer also assists users with complex documentation activities supporting regulatory
submissions and investigations. As a Risk Management and Design Controls expert, the Design Controls
Engineer assists users on data governance, compliance (including GDP), and quality assurance of DHF
documentation used for regulatory submissions and audit. Essential Job Duties - Provide coaching and mentorship to development, manufacturing, and other stakeholders oncontent development, quality processes, risk analysis and Design Controls tools - Work with ALM developers to identify and capture learning content for tool features including best practices - Develop content for, review, and effectively deliver training to optimize efficacy and learner experience through channels such as online learning modules, instructor-led training, written instructional solutions, short content videos, and virtual training for users of Design Control tools - Respond to ticket-based requests from a variety of user channels supporting design teams - Research, recommend, and implement new authoring tools to improve learner experience - Monitor effectiveness of learning programs and materials and augment training content based on user feedback. - Provide user feedback to the new product/feature development team to ensure user adoption of new features - Drive standardization of design control documents via stakeholder engagement meetings while - ensure Good Documentation Practices (GDP) are followed - Be an ECO mentor for document ECO creator qualification, while regularly identifying new candidates to nominate for ECO document creator access The following job duties are secondary and will decrease over time with wider tool adoption and
increased user skills: - Assist the new product development team with compiling and updating documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation - Build, produce, and refine complex trace reports using standard report templates. - Create additional custom reports as needed - Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive’s design control process - In some cases, help author and deliver documentation and Engineering Change Orders (ECOs) related to complex documentation (e.g. complex risk analysis documents) for major design reviews
Required Skills and Experience - Bachelor’s degree in engineering, science or other technical area - Minimum of 3 years of experience in a technical field, medical devices preferred - Stay current on medical devices standards for Risk Management (ISO 14971) Design Controls (ISO 13485) and FDA design control requirements (21 CFR Part 820) - Experience working in an ISO 13485 medical device product development environment or other regulated industry - Experience writing and reviewing Engineering and manufacturing (design control) documents,
including risk analysis, requirements, specifications, test protocols and test reports - Skilled in the use of Agile or similar product lifecycle management (PLM) system tool - Skilled in the use of Polarion or similar requirements management tool (ALM) - Experience working with a Learning Management System (LMS) Preferred Skills and Experience - Ability
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