Senior Software Quality Assurance Engineer - Medical Devices

Job Description:

Minneapolis, MN (Remote)$110,000-$150,000 + 10% Bonus Plan

The Opportunity

You'll serve as a core quality engineering team member on software and firmware development for novel neuromodulation devices used to treat epilepsy and sleep apnea. This role puts you at the intersection of product development and regulatory compliance, where your technical leadership directly shapes the safety and quality of implantable medical devices. You'll own the risk management file, drive design control compliance, and guide teams through the full software development lifecycle under IEC 62304.

Why You'll Love This Role

• Work on cutting-edge implantable neuromodulation devices making a real difference for patients with epilepsy and sleep apnea
• Fully remote position
• Competitive compensation with a 10% bonus plan

Your Day-to-Day

• Provide technical leadership and direction on software/firmware product development teams, owning risk management documentation, design requirements, architecture specifications, and design verification/validation - including unit and integration testing
• Chair the change control board within projects, managing change requests and defects identified during development
• Lead investigations into software/firmware-related complaints, manufacturing nonconformities, audit responses, and CAPAs - identifying root cause and driving corrective actions
• Deliver technical feedback through code reviews that strengthen code quality and compliance
• Generate, maintain, and update risk management documentation throughout the full product lifecycle
• Ensure compliance with software/firmware development procedures and non-product software validation procedures, including automated manufacturing test systems
• Support regulatory audits by coordinating back room/front room activities or serving as a subject matter expert
• Build and maintain strong working relationships with R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities and ensure company-wide regulatory compliance

What We're Looking For

• BS in Computer Engineering, Computer Science, Electrical Engineering (with software development education/experience), or a related degree
• 5+ years of experience developing software or firmware in the medical device industry with demonstrated proficiency meeting IEC 62304 requirements
• In-depth knowledge of pertinent regulations including ISO 13485 and 21 CFR Part 820
• Full accountability for representing Quality Engineering on project teams
• Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections
• Strong leadership skills with the ability to influence peers and cross-functional team members
• Excellent written and verbal communication skills
• Strong prioritization and planning abilities
• Advanced degree or professional certifications are valued
• Experience with implantable medical devices is a significant plus

Note: This is a Software Quality Assurance Engineering role - not a software test engineer position.

Ready to Apply?

If you're a medical device software quality professional ready to apply your IEC 62304 expertise to life-changing neuromodulation technology, we want to hear from you. Submit your resume today - your information will not be shared with the hiring company without your permission.

Required Skills:

• Resume

• Project Teams

• Leadership Skills

• Support

• Development

• Driving

• ROOT

• Integration Testing

• Operations

• Assurance

• Compliance

• Hiring

• Corrective Actions

• Electrical Engineering

• Accountability

• Regulatory Compliance

• Compensation

• Reviews

• Validation

• Product Development

• Deliverables

• Architecture

• Software Development

• Manufacturing

• Quality Assurance

• Specifications

• Risk Management

• Communication Skills

• Integration

• Regulations

• Computer Science

• Education

• Software

• Testing

• Documentation

• Planning

• Design

• Engineering

• Science

• Leadership

• Communication

• Management