Design Control Engineer 3
Core
Design Control Engineer supporting the design and development of safe, effective, and compliant medical device products by assisting engineering teams with regulatory and quality documentation deliverables.
Role type
Design Control Engineer (Medical Devices)
Builds
Design History Files (DHF), risk analyses, requirements, specifications, test protocols, and trace reports for regulatory submissions.
Domain
Medical Devices / Regulatory Quality
Required skills
Design Controls (ISO 13485, 21 CFR Part 820), Risk Management (ISO 14971), Engineering Change Orders (ECO), Requirements Management (Polarion/ALM), Learning Management Systems (LMS), Good Documentation Practices (GDP), Agile/PLM tools
Preferred skills
Cross-functional collaboration, Strategic planning, Time management, Emotional intelligence, Service orientation, Technical writing, Microsoft Office Suite, Coaching and mentoring
Technologies
Polarion, ALM, LMS, Microsoft Excel, Word, PowerPoint
Responsibilities
Provide coaching and mentorship on quality processes and Design Controls tools; Develop and deliver training content (online modules, instructor-led, videos); Respond to user support tickets; Drive standardization of design control documents; Assist in compiling Design History Files and creating trace reports; Mentor ECO document creators.
Seniority
Mid-level, hands-on IC