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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