Role & seniority: Design Quality Engineer, with 6+ years in medical devices; senior/experienced level.

Stack/tools: Medical device regulations (ISO 13485, FDA, EU MDR); Design Control processes (Design Input/Output, Verification, Validation); Risk Management (RM plan, Hazard Analysis, DFMEA, UFMEA, RM report); Design History Files (DHF), Technical File submissions for 510(k) and CE mark; cross-functional collaboration; software deliverables review.

Top 3 responsibilities

Compile and review Design History Files and technical submissions for 510(k) and CE mark; approve design history with cross-functional teams.
Lead risk management activities: RM plan, Hazard Analysis, DFMEA/UFMEA, risk reporting; ensure risk controls are integrated into design.
Support design control execution across the project (design inputs/outputs, verification/validation); qualify product development equipment; develop/validate test methods.

Must-have skills: 6+ years in medical device design quality; strong regulatory knowledge (ISO 13485, FDA, EU MDR); experience with DHF/Technical File submissions; risk management documentation (RM plan, DFMEA/UFMEA); cross-functional collaboration; strong communication and analytical/problem-solving abilities.
Nice-to-haves: Experience with software deliverables and software aspects of design control; hands-on experience with equipment qualification and method development; demonstrated ability to navigate regulatory submissions a

Full Description

Dice is the leading career destination for tech experts at every stage of their careers. Our client, VDart, Inc., is seeking the following. Apply via Dice today!

Title: Design Quality Engineer

Location: Plano, TX (onsite)

Job Description

6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical and New Product Development. Good experience in Medical devices regulations ISO13485, FDA & EU MDR regulations Experience in compiling Design history files & Technical file submission for 510k & CE mark Own Risk Management files Risk management plan, Hazard Analysis, DFMEA, UFMEA, Risk Management report Work with cross functional teams to execute and/or support various areas of Design Control processes, such as Design Input requirements, Design Outputs, Design Verification and Design Validation. Review & approve all the design history files with cross functional teams (including software deliverables) Support product development equipment qualification activities, test method development and validation activities. Strong in Medical devices technical documentation Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization. Strong analytical/problem solving, critical thinking, and presentation skills.