Software Quality Engineer II

The Software Quality Engineer II supports the development and lifecycle management of software used in medical devices by ensuring quality, compliance, and effective risk management throughout the product lifecycle. This role partners closely with Software Engineering, Systems Engineering, Regulatory Affairs, and Product Development teams to provide quality oversight from concept through commercialization.

The Software Quality Engineer II is responsible for reviewing software design and development deliverables, supporting verification and validation activities, assessing software changes, and ensuring compliance with applicable domestic and international regulations and standards. This position also contributes to continuous improvement initiatives, complaint investigations, CAPA activities, and post-market quality processes.

Success in this role requires strong knowledge of software quality principles, medical device regulations, software development processes, and the ability to collaborate effectively in a fast-paced cross-functional environment.

• →Partner with software development and cross-functional teams to ensure quality is integrated throughout the software development lifecycle. 
• →Review and approve software development deliverables including requirements, architecture, risk documentation, test protocols, traceability, and validation records. 
• →Support design control activities in compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and other applicable global requirements. 
• →Participate in design reviews, phase gate reviews, and change control activities for software-based products and systems. 
• →Review software verification and validation activities including unit, integration, system, cybersecurity, and user acceptance testing. 
• →Support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification. 
• →Evaluate software defects, nonconformances, and quality events to determine product impact and required actions. 
• →Participate in CAPA, complaint investigations, post-market surveillance, and field issue assessments involving software-related products. 
• →Support internal audits, external audits, and regulatory inspections by preparing documentation and providing subject matter expertise. 
• →Drive continuous improvement initiatives to strengthen software quality systems, processes, and compliance effectiveness. 
• →Assist in the creation, review, and maintenance of Design History Files (DHF), Device Master Records (DMR), and quality records. 
• →Mentor junior team members and provide guidance on software quality processes and best practices as needed. 
• →Perform other duties or special projects as assigned.

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline. 

• Minimum 3 years of experience in Quality Engineering, Quality Assurance, or Software Quality within a regulated industry. 

• Working knowledge of software development lifecycle (SDLC), Agile and/or waterfall development methodologies. 

• Experience supporting software verification and validation activities. 

• Knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971. 

• Experience with change control, nonconformance, CAPA, and complaint handling processes. 

• Strong analytical, problem-solving, and risk assessment skills. 

• Strong written and verbal communication skills with the ability to work cross-functionally. 

• Proficiency with Microsoft Office applications and quality documentation systems.

• Experience supporting Software as a Medical Device (SaMD), embedded software, connected devices, or cybersecurity-focused products. 

• Experience with automated test tools, defect tracking systems, or application lifecycle management systems. 

• Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent certification. 

• Experience in the medical device industry strongly preferred. 

• Master’s degree in a related technical discipline.

• Ability to read, write, and communicate effectively in English.
• Ability to interpret technical documents, schematics, and written instructions.
• Ability to clearly document technical findings and communicate with cross-functional team members. 

This position primarily works in an office environment and requires frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may require standing for extended periods when facilitating meetings or walking through facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.  Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline required; advanced degree preferred.