Design Quality Assurance Engineer

We are seeking a knowledgeable and detail-oriented Design Assurance / Quality Assurance Engineer to serve as the quality and regulatory standards expert within our R&D organization. This individual will be embedded within the product development team and will provide hands‑on guidance to hardware engineers, firmware developers, and software engineers throughout the product lifecycle - from concept through design transfer, FDA submission, and post‑market surveillance - with a focus on ensuring design history file documentation is suitable for 510(k) submission.

About the Role

The ideal candidate possesses deep working knowledge of medical device product development standards including ISO 14971, IEC 62304, IEC 62366, and IEC 60601, and understands how to apply these standards practically to streamline FDA regulatory submissions. This role bridges the gap between engineering execution and regulatory compliance, ensuring that design outputs, verification/validation activities, and technical documentation meet the expectations of FDA reviewers and notified bodies.

This is not a manufacturing‑floor quality role. The Design Assurance/ QA Engineer will work side‑by‑side with R&D teams during active development, proactively identifying compliance gaps, guiding documentation practices, and ensuring that quality is built into the documentation for every phase of design, not inspected in after the fact.

Responsibilities

• Design Controls & Product Development Quality:
• Serve as the in‑house standards expert, providing real‑time guidance to hardware and software development teams on FDA Design Controls (21 CFR 820), ISO 13485, and related product development standards.
• Lead and facilitate design control activities including definition of design inputs, design outputs, design reviews, design verification, design validation, and design transfer documentation.
• Ensure design control deliverables are complete, traceable, and audit‑ready throughout the product development lifecycle.
• Develop and maintain Design History File (DHF) templates / indices, checklists, and procedures that streamline regulatory submission preparation.
• Participate actively in design review meetings, providing quality and regulatory perspective on engineering decisions and trade‑offs.
• Collaborate with R&D Project Manager to integrate quality milestones into project schedules and stage‑gate reviews.
• Lead risk management activities across all product development programs in accordance with ISO 14971, including hazard identification, risk analysis, risk evaluation, risk control, and residual risk assessment.
• Facilitate creation and maintenance of risk management files including risk management plans, Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), and benefit‑risk analyses.
• Ensure traceability between identified hazards, risk controls, and verification/validation activities.
• Guide hardware and software engineers in identifying risk implications of design decisions early in the development process, for both new product development and sustaining activities.
• Support post‑market risk monitoring and ensure risk management files are updated based on field data, complaints, and adverse event reports.
• Software Lifecycle Quality (IEC 62304):
• Provide guidance to software development teams on IEC 62304 compliance, including software safety classification, software development planning, software requirements, architecture, detailed design, unit testing, integration testing, and system testing.
• Review and approve software development documentation including software requirements specifications (SRS), software architecture documents (SAD), software design specifications (SDS), and software test plans/reports.
• Ensure software change control…