Medical Devices, Design Assurance Engineer

Meta • New York, NY

27d

About The Position

We are seeking an experienced medical devices quality management systems professional to join us and contribute as a Design Assurance engineer in our quality management system (QMS) compliant with 21 CFR, EU MDR, and ISO 13485 for the organization. You will work cross functionally in an organization that is primarily consumer electronics focused but has a growing medical device portfolio to champion the adoption of processes. You will act as the directly responsible individual for Design Assurance deliverables (aka Design Controls and the Design History File) for software as a medical device (SaMD) programs.

Requirements

• Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience
• 8+ years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development)
• Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience
• Demonstrated experience communicating at a technical level with software engineers on architecture, requirements, and risk controls

Nice To Haves

• Experience with electronic Quality Management System and SW Development tools for automated documentation and record keeping practices
• Experience and personal interactions with FDA and other regulatory agencies through audits and product submissions
• Certified Quality Auditor or Certified Quality Engineer

Responsibilities

• Lead and execute design control activities for medical device projects, ensuring compliance with regulatory requirements (FDA, ISO 13485, etc.) and internal Quality Management System (QMS) standards
• Develop, maintain, and review essential design documentation, including Design and Development Plans, Product Requirements D, Functional Requirements, Bill of Materials, Verification and Validation Plans and Results, Risk Management Files, and Design History Files
• Implement and oversee change control processes for design changes, including assessment of impact, documentation, and regulatory compliance, especially for Software as a Medical Device (SaMD) platforms
• Collaborate cross-functionally with engineering, regulatory, product, and safety teams to ensure design inputs, outputs, and risk management activities are integrated and aligned
• Support regulatory submissions (e.g., 510k, DeNovo), ensuring design documentation and testing meet regulatory expectations for safety, effectiveness, and cybersecurity (for connected devices)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level