Design Quality Assurance Engineer

About the Company

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.
• Risk Management (ISO 14971):
• 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 processes comply with IEC 62304 maintenance requirements and that problem resolution activities are properly documented.
• Advise on software verification and validation strategies aligned with FDA’s Guidance on Content of Premarket Submissions for Device Software Functions.
• Support SOUP (Software of Unknown Provenance) risk analysis and management activities.
• Usability Engineering (IEC 62366):
• Guide R&D teams in applying IEC 62366 usability engineering processes throughout product development, from use specification through formative and summative usability evaluations.
• Support creation of use-related risk analysis documents and ensure usability requirements are integrated into design inputs.
• Review usability evaluation plans and reports; ensure findings are incorporated into design iterations.
• Collaborate with UX/UI designers and clinical team to ensure usability documentation supports FDA Human Factors submissions.
• Electrical Safety& Performance (IEC 60601 Series):
• Provide quality oversight for hardware development activities related to IEC 60601-1(General Safety), IEC 60601-1-2 (EMC), and applicable particular standards (e.g., IEC 60601-2-47 for ambulatory ECG systems).
• Guide electrical and mechanical engineers in designing for compliance with essential performance requirements, means of protection, and safety classification decisions.
• Coordinate with external test laboratories for IEC 60601 testing, review test plans and reports, and support resolution of non-conformities identified during safety testing.
• Ensure test evidence and declarations of conformity are properly documented for inclusion in regulatory submission packages.
• FDA Submission Support:
• Serve as a key contributor to FDA regulatory submissions (510(k) or Letter to File), ensuring that technical documentation packages are complete, consistent, and meet reviewer expectations.
• Prepare and organize submission-ready documentation including performance data summaries, standards compliance matrices, software documentation, risk management summaries, and biocompatibility rationale.
• Develop and maintain standards compliance checklists and gap analysis templates that accelerate submission preparation timelines.
• Support pre-submission (Q-Sub) meeting preparation by identifying key regulatory questions and compiling supporting technical evidence.
• Stay current on FDA guidance documents, recognized consensus standards, and regulatory policy updates that impact product development strategy.
• Quality Management System (QMS) Integration:
• Ensure R&D processes and documentation comply with the company’s ISO 13485-certified Quality Management System.
• Author and maintain Standard Operating Procedures (SOPs), work instructions, and templates related to design assurance and product development quality.
• Support internal and external audit activities (FDA, ISO, supplier audits) by preparing documentation, coordinating responses, and driving corrective actions to closure