Design Control Engineer 3

Intuitive•Sunnyvale, CA

8h•$101,900 - $162,800•Onsite

About The Position

The Design Control Engineer is a contributor within the Product Quality organization who supports 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 training for Design Controls tools. As a process and tools expert, the engineer also supports complex documentation activities for regulatory submissions and investigations, data governance, compliance (including Good Documentation Practices), and DHF documentation quality assurance for submissions and audits. The position primarily coaches stakeholders, develops and delivers learning materials, supports users through ticket-based requests, improves authoring tools and training, gathers feedback, and drives document standardization and ECO creator qualification. Secondary duties include helping compile and update DHF documents, preparing trace reports, assisting with document authoring and review, and in some cases preparing complex documentation and Engineering Change Orders for major design reviews. The position is listed as a day-shift role, with a set schedule and weekly onsite work; the percentage of onsite work is determined by the leader.

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.
Stay current on medical device 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 another regulated industry.
Experience writing and reviewing engineering and manufacturing design control documents, including risk analyses, requirements, specifications, test protocols, and test reports.
Skilled in using an Agile or similar product lifecycle management (PLM) system tool.
Skilled in 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 necessary.
Ability to develop solution-oriented strategies and meet 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.
Skilled in 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 modules, instructor-led sessions, written instructional materials, 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 the effectiveness of learning programs and materials and update training content based on user feedback.
Provide user feedback to new product and feature development teams to support adoption of new features.
Drive standardization of design control documents through stakeholder engagement and ensure Good Documentation Practices are followed.
Mentor ECO document creator qualification and identify candidates for ECO document creator access.
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 complex trace reports using standard templates, and create custom reports when needed.
Assist subject matter experts with writing, reviewing, and editing documents required by the design control process.
When needed, help author and deliver documentation and Engineering Change Orders related to complex documentation for major design reviews.