Design Control Engineer 3

Intuitive•Sunnyvale, CA

1d•$101,900 - $162,800•Onsite

About The 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.

Requirements

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)

Nice To Haves

Ability to work cross-functionally as well as operate independently when necessary
Ability to create solution oriented strategies and execute on goals within set timelines and budgets
Solid organizational, time management and prioritization skills
Strong interpersonal skills and emotional intelligence
Ability to manage challenging assignments and multiple assignments in parallel
Strong service-oriented qualities with an ability to work collaboratively with multiple Engineering teams
Excellent writing and communication skills, and attention to detail
Skilled in the use of Microsoft Excel, Word, and PowerPoint
Ability to develop others through structured learning experience, feedback strategies, and coaching

Responsibilities

Provide coaching and mentorship to development, manufacturing, and other stakeholders on content 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
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