Sr Software Quality Assurance Engineer
- Medical Device 5.0 5.0 out of 5 stars Minneapolis, MN Remote $110,000
- $150,000 a year
- Full-time ilocatum 6 reviews $110,000
- $150,000 a year
- Full-time Sr SW Quality Assurance Engineer Minneapolis, MN (Remote) | Full-Time A medical device company focused on novel neuromodulation technology for the treatment of epilepsy and sleep apnea is hiring a Software Quality Assurance Engineer to join its product development organization.
This is a fully remote position with core responsibilities spanning software and firmware quality engineering across both product and non-product systems, including automated manufacturing test environments. The role is a technical contributor position, not a software test engineer role, and requires hands-on ownership of design control, risk management, and regulatory compliance activities.
Schedule:
Full-time, remote
Compensation:
$110,000
- $150,000 Per Year What You'll Do You will serve as a core team member on software and firmware product development projects, providing technical leadership on quality engineering activities throughout the product lifecycle.
Your primary ownership areas include the risk management file, design control compliance, development of design requirements and architecture specifications, and design verification and validation, covering both unit and integration testing. You will chair the change control board within assigned projects, managing change requests and defects identified during development. As the technical expert for software and firmware quality on your teams, you will lead and approve investigations into software-related complaints, manufacturing nonconformances, audit findings, and CAPAs, working to identify root cause and corrective actions within established timelines. You will also provide substantive technical feedback during code reviews. Regulatory readiness is a consistent part of the role. You will generate, maintain, and update risk management documentation across the product lifecycle and ensure that software and firmware development activities comply with internal procedures and applicable regulations. During regulatory audits and inspections, you may coordinate back room and front room activities or serve as a subject matter expert, and you will be accountable for presenting procedural requirements and design deliverables clearly in those settings. Collaboration is central to this position. You will build and maintain working relationships with R D, Clinical, Regulatory Affairs, and Operations to support design development, audit preparedness, and ongoing compliance with regulatory requirements. Required Qualifications 5 or more years of experience in software or firmware development or quality engineering within the medical device industry Demonstrated proficiency with
IEC 62304
(Software Life Cycle Processes for Medical Device Software) In-depth working knowledge of ISO 13485 and 21 CFR Part 820 Experience with risk management documentation and processes across the full product lifecycle Proven ability to lead root cause investigations, CAPAs, and defect resolution in a regulated environment Strong written and verbal communication skills, including the ability to present clearly during audits and regulatory inspections Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering (with software development coursework or experience), or a related field Preferred Qualifications Experience with implantable or active implantable medical devices Familiarity with neuromodulation device development Experience with non-product software validation, including automated manufacturing test systems Advanced degree in a relevant engineering or scientific discipline Professional certifications in quality engineering (ASQ CQE or equivalent) Experience coordinating regulatory inspections or audit readiness activities Compensation and Benefits Competitive base salary commensurate with experience Medical, dental, and vision insurance 401(k) retirement plan Paid time off Fully remote work arrangement To apply, submit your resume along with a brief description of your
IEC 62304
experience and the types of medical devices you have worked on.
