NG
Quality Assurance Engineer
Accepting applicationsNuWest Group · Bellevue, WA
Full-Time Mid_senior AIMentoraiaterf
Posted
1d ago
Category
Test
Experience
Mid_senior
Country
United States
Design Assurance / Quality Assurance Engineer
Position Overview
We are seeking a skilled Design Assurance / QA Engineer to serve as the quality and regulatory expert in our R&D team. You will collaborate with hardware, software, and firmware engineers to ensure compliance throughout the product lifecycle, from concept to FDA submission. Your focus will be on maintaining design history files (DHF) for 510(k) submissions and ensuring adherence to medical device standards (ISO 14971, IEC 62304, IEC 62366, IEC 60601).
This is a proactive role within development, not a manufacturing-floor quality position. You will guide teams on quality, risk, and regulatory requirements while supporting smooth FDA submissions.
Key Responsibilities
Design Control & Documentation:
Provide guidance on FDA Design Controls, ISO 13485, and related standards.
Lead design control activities (inputs, outputs, reviews, validation) and ensure traceability across the product lifecycle.
Develop DHF templates and participate in design reviews with a focus on regulatory compliance.
Risk Management (ISO 14971):
Lead risk management across hardware and software, ensuring compliance with ISO 14971.
Facilitate creation of risk management files (e.g., FMEA, FTA) and ensure traceability to design decisions.
Software Lifecycle (IEC 62304):
Guide software teams on compliance with IEC 62304, including development planning, requirements, and testing.
Ensure software documentation (SRS, SDS) meets regulatory standards.
Usability Engineering (IEC 62366):
Support usability evaluations, ensuring integration of human factors in product design for FDA submissions.
Electrical Safety (IEC 60601):
Oversee compliance with IEC 60601-1 and related standards for hardware development, ensuring safety and performance.
FDA Submissions & Compliance:
Contribute to 510(k) submissions, ensuring complete, audit-ready documentation.
Stay updated on FDA guidance and support pre-submission preparation.
QMS Integration:
Ensure R&D processes align with ISO 13485 QMS.
Lead audit preparations and corrective actions, and improve design assurance processes.
Training & Cross-Functional Guidance:
Mentor engineering teams on regulatory expectations and best practices.
Serve as the key liaison between R&D, Regulatory Affairs, and Quality Assurance.
Qualifications
Required:
Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, Software)
5+ years in design assurance or QA within medical device development
Expertise in ISO 14971, IEC 62304, IEC 62366, IEC 60601
Experience with FDA 510(k) submissions and design control processes
Strong communication skills and attention to detail
Preferred:
Experience with cardiac monitoring, ECG devices, or active medical devices
ASQ Certified Quality Engineer or Regulatory Affairs Certification
Familiarity with cloud-based platforms (e.g., SaaS/SaMD), AI/ML-based devices, and international regulatory standards (EU MDR, MDSAP)
Core Competencies
Standards Mastery: Deep, practical knowledge of medical device standards applied during product development
Regulatory Fluency: Expertise in structuring documentation for streamlined FDA submissions
Collaboration: Ability to work closely with engineering teams while ensuring compliance
Documentation Excellence: Producing clear, traceable, and audit-ready documentation
Risk Management: Identifying and mitigating compliance risks early in the design process
Continuous Improvement: Driving process improvements based on audits and lessons learned
Show more Show less
Position Overview
We are seeking a skilled Design Assurance / QA Engineer to serve as the quality and regulatory expert in our R&D team. You will collaborate with hardware, software, and firmware engineers to ensure compliance throughout the product lifecycle, from concept to FDA submission. Your focus will be on maintaining design history files (DHF) for 510(k) submissions and ensuring adherence to medical device standards (ISO 14971, IEC 62304, IEC 62366, IEC 60601).
This is a proactive role within development, not a manufacturing-floor quality position. You will guide teams on quality, risk, and regulatory requirements while supporting smooth FDA submissions.
Key Responsibilities
Design Control & Documentation:
Provide guidance on FDA Design Controls, ISO 13485, and related standards.
Lead design control activities (inputs, outputs, reviews, validation) and ensure traceability across the product lifecycle.
Develop DHF templates and participate in design reviews with a focus on regulatory compliance.
Risk Management (ISO 14971):
Lead risk management across hardware and software, ensuring compliance with ISO 14971.
Facilitate creation of risk management files (e.g., FMEA, FTA) and ensure traceability to design decisions.
Software Lifecycle (IEC 62304):
Guide software teams on compliance with IEC 62304, including development planning, requirements, and testing.
Ensure software documentation (SRS, SDS) meets regulatory standards.
Usability Engineering (IEC 62366):
Support usability evaluations, ensuring integration of human factors in product design for FDA submissions.
Electrical Safety (IEC 60601):
Oversee compliance with IEC 60601-1 and related standards for hardware development, ensuring safety and performance.
FDA Submissions & Compliance:
Contribute to 510(k) submissions, ensuring complete, audit-ready documentation.
Stay updated on FDA guidance and support pre-submission preparation.
QMS Integration:
Ensure R&D processes align with ISO 13485 QMS.
Lead audit preparations and corrective actions, and improve design assurance processes.
Training & Cross-Functional Guidance:
Mentor engineering teams on regulatory expectations and best practices.
Serve as the key liaison between R&D, Regulatory Affairs, and Quality Assurance.
Qualifications
Required:
Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, Software)
5+ years in design assurance or QA within medical device development
Expertise in ISO 14971, IEC 62304, IEC 62366, IEC 60601
Experience with FDA 510(k) submissions and design control processes
Strong communication skills and attention to detail
Preferred:
Experience with cardiac monitoring, ECG devices, or active medical devices
ASQ Certified Quality Engineer or Regulatory Affairs Certification
Familiarity with cloud-based platforms (e.g., SaaS/SaMD), AI/ML-based devices, and international regulatory standards (EU MDR, MDSAP)
Core Competencies
Standards Mastery: Deep, practical knowledge of medical device standards applied during product development
Regulatory Fluency: Expertise in structuring documentation for streamlined FDA submissions
Collaboration: Ability to work closely with engineering teams while ensuring compliance
Documentation Excellence: Producing clear, traceable, and audit-ready documentation
Risk Management: Identifying and mitigating compliance risks early in the design process
Continuous Improvement: Driving process improvements based on audits and lessons learned
Show more Show less