Design Control Engineer 3

Intuitive•Sunnyvale, CA

About The Position

The Design Control Engineer is a contributor within Intuitive’s Product Quality organization, supporting the design and development of safe, effective, and compliant medical device products. The role assists and trains Design Engineering and New Product Introduction teams on regulatory and quality documentation deliverables for Design Control milestones and Design History File (DHF) maintenance. It provides direct user support and develops and delivers content and training for Design Controls tools. As a process and tools expert, the engineer also supports complex documentation activities for regulatory submissions and investigations, and advises users on data governance, compliance—including Good Documentation Practices (GDP)—and DHF documentation quality for submissions and audits. The position focuses on coaching stakeholders, developing and delivering learning materials, responding to support requests, improving tools and training, and promoting standardized, high-quality design control documentation. Secondary duties include supporting DHF compilation and maintenance, preparing trace reports, assisting with design control documents, and in some cases authoring complex documentation and Engineering Change Orders (ECOs).

Requirements

Bachelor’s degree in engineering, science, or another technical area.
At least 3 years of experience in a technical field; medical-device experience is preferred.
Current knowledge of medical-device standards for Risk Management (ISO 14971), Design Controls (ISO 13485), and FDA design control requirements (21 CFR Part 820).
Experience in an ISO 13485 medical-device product-development environment or another regulated industry.
Experience writing and reviewing engineering and manufacturing design-control documents, including risk analyses, requirements, specifications, test protocols, and test reports.
Skill using an Agile or similar product lifecycle management (PLM) system tool.
Skill using Polarion or a similar requirements management (ALM) tool.
Experience working with a Learning Management System (LMS).

Nice To Haves

Ability to work cross-functionally and independently when needed.
Ability to develop solution-oriented strategies and execute goals within set timelines and budgets.
Strong organizational, time-management, and prioritization skills.
Strong interpersonal skills and emotional intelligence.
Ability to manage challenging assignments and multiple assignments in parallel.
Service-oriented approach and ability to collaborate with multiple Engineering teams.
Excellent writing and communication skills, with attention to detail.
Skill using Microsoft Excel, Word, and PowerPoint.
Ability to develop others through structured learning experiences, feedback strategies, and coaching.

Responsibilities

Coach and mentor 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, review, and deliver training through online learning modules, instructor-led sessions, written instructions, short videos, and virtual training.
Respond to ticket-based requests from users supporting design teams.
Research, recommend, and implement authoring tools to improve the learner experience.
Monitor learning-program effectiveness, improve training based on user feedback, and provide feedback to new product and feature development teams to support user adoption.
Drive standardization of design control documents through stakeholder meetings and ensure Good Documentation Practices are followed.
Mentor users seeking qualification as ECO document creators and identify candidates for ECO document-creator access.
As secondary duties, assist new product development teams with compiling and updating DHF documents, including risk analyses, requirements, trace reports, and design verification and validation test documentation.
Build, produce, and refine trace reports using standard templates, and create custom reports when needed.
Assist subject matter experts with writing, reviewing, and editing documents required by Intuitive’s design control process.
In some cases, author and deliver documentation and ECOs for complex documentation activities, such as complex risk analyses for major design reviews.