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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