QA Engineer(Firmware) - Medical Devices

Job Title - Senior QA Engineer – Firmware & Medical Devices

Location - Minneapolis, Minnesota (Fully Remote)

Employment Type - Full-Time

Interview Mode:
Virtual Interview

About the Role

We are seeking an experienced
Senior QA Engineer – Firmware & Medical Devices
to support the development, validation, compliance, and quality assurance of medical device software and firmware systems.

This is a senior-level role responsible for serving as a core member of software/firmware product development teams while ensuring compliance with medical device regulations, risk management standards, and design control processes.

The ideal candidate will bring strong expertise in medical device firmware/software quality engineering, IEC 62304, ISO 13485, FDA 21 CFR Part 820, risk management, CAPA investigations, validation/testing, and regulatory audit support.

Key Responsibilities

Software/Firmware Quality Engineering
• Serve as a core Quality Engineering team member within software and firmware product development initiatives
• Provide technical leadership and guidance throughout the software/firmware development lifecycle
• Support both product and non-product software systems, including automated manufacturing test systems

Design Controls & Compliance
• Lead and support compliance activities related to:

– IEC 62304

– ISO 13485

– FDA 21 CFR Part 820

– Medical Device Design Controls
• Develop and maintain design requirements, architecture specifications, and verification/validation documentation
• Ensure compliance with software and firmware development procedures and validation standards

Risk Management & Validation
• Own and maintain software/firmware risk management files throughout the product lifecycle
• Lead design verification and validation activities including:

– Unit Testing

– Integration Testing

– Design Validation

– Defect Management
• Support compliant, effective, and efficient quality processes aligned with regulatory expectations

CAPA, Investigations & Audit Support
• Lead investigations related to:

– Software/Firmware Complaints

– Manufacturing Nonconformities

– Development Defects

– CAPAs
• Identify root causes and corrective/preventive actions in a timely manner
• Provide support during regulatory audits and inspections by acting as a subject matter expert
• Coordinate back-room/front-room audit activities as required

Change Control & Technical Reviews
• Chair Change Control Board activities for project-related defects and change requests
• Participate in and provide technical feedback during code reviews
• Ensure documentation accuracy, traceability, and regulatory compliance across all development activities

Cross-Functional Collaboration
• Partner closely with:

– R&D

– Clinical Teams

– Regulatory Affairs

– Operations

– Quality Teams
• Support product development, compliance initiatives, and quality objectives across the organization

Mandatory Skills & Qualifications

Medical Device & Firmware Quality Expertise
• 5+ years of experience in software/firmware quality engineering within the medical device industry
• Strong hands-on experience with IEC 62304 compliance and medical device software lifecycle processes
• Experience supporting firmware and software validation within regulated medical device environments

Regulatory & Compliance Experience
• Strong knowledge of:

– ISO 13485

– FDA 21 CFR Part 820

– Risk Management Processes

– Design Controls

– CAPA & Audit Readiness
• Experience supporting regulatory inspections and quality audits

Technical & Leadership Skills
• Experience leading software/firmware investigations and root cause analysis
• Strong technical review and validation experience
• Ability to influence teams and provide technical leadership across cross-functional environments
• Strong written and verbal communication skills

Education
• Bachelor’s Degree in:

– Computer Engineering

– Computer Science

– Electrical Engineering

– Related Technical Discipline
• Advanced degrees and professional certifications are highly valued

Preferred Skills

• Experience with implantable medical devices
(Highly Preferred)
• Experience supporting automated manufacturing test systems
• Strong firmware/software architecture understanding
• Experience working within highly regulated healthcare environments

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