Software Quality Engineer

ATR International; Lafayette (CO); On-site; USD 85,000 - 110,000; Full time

Job summary

ATR International is seeking a Software Quality Engineer II to support medical device software development and software products. The role partners with R&D, Quality, and software teams to strengthen software lifecycle processes, maintain quality system documentation, and support product compliance.

The primary focus includes design quality engineering under IEC 62304, QMS process development, and cloud-based software support.

Qualifications

• Bachelor’s degree in a relevant discipline with at least 2 years of relevant experience, or an advanced degree.
• Practical knowledge of software design quality engineering and IEC 62304.
• Experience developing or implementing QMS processes, procedures, and quality documentation.
• Experience supporting cloud-based software from a quality engineering or software lifecycle perspective.
• Knowledge of computer/software validation, design controls, and medical device change control.
• Understanding of ISO 13485 and EU MDR, and familiarity with US/EU regulatory frameworks.
• Understanding of non-medical software product development processes and lifecycle requirements.
• Strong documentation, communication, and cross-functional collaboration skills.
• Ability to explain quality requirements and provide guidance and training to technical teams.

Responsibilities

• Provide software design quality guidance throughout development, including requirements, design, integration, testing, verification, validation, and maintenance.
• Apply IEC 62304 and design control principles to software development activities and deliverables.
• Develop, update, and implement QMS processes, procedures, and supporting documentation for medical device software, commercial software, and AI-enabled applications.
• Provide quality engineering support for cloud-based software and collaborate with teams responsible for ongoing software support.
• Review software requirements, design documentation, test plans, and change specifications for compliance with applicable procedures and requirements.
• Support computer and software validation, including requirements traceability and testability.
• Evaluate medical device software changes and support change control activities.
• Support defect analysis, failure investigations, and process improvements.
• Develop and deliver training on quality processes and procedures for cross-functional teams.
• Help assess evolving regulatory requirements and incorporate necessary changes into software quality practices.

Education

Bachelor’s degree in a relevant discipline

Advanced degree

Job description

We are seeking a Software Quality Engineer II to support medical device software development and commercially available software products. This role partners with R&D, Quality, and software teams to strengthen software lifecycle processes, maintain quality system documentation, and support product compliance.

The primary focus areas are design quality engineering under IEC 62304, QMS process and procedure development, and cloud-based software support.

Key Responsibilities

• Provide software design quality guidance throughout development, including requirements, design, integration, testing, verification, validation, and maintenance.
• Apply IEC 62304 and design control principles to software development activities and deliverables.
• Develop, update, and implement QMS processes, procedures, and supporting documentation for medical device software, commercial software, and AI-enabled applications.
• Provide quality engineering support for cloud-based software and collaborate with teams responsible for ongoing software support.
• Review software requirements, design documentation, test plans, and change specifications for compliance with applicable procedures and requirements.
• Support computer and software validation, including requirements traceability and testability.
• Evaluate medical device software changes and support change control activities.
• Support defect analysis, failure investigations, and process improvements.
• Develop and deliver training on quality processes and procedures for cross-functional teams.
• Help assess evolving regulatory requirements and incorporate necessary changes into software quality practices.

Required Qualifications

• Bachelor’s degree in a relevant discipline with at least 2 years of relevant experience, or an advanced degree with no prior experience required.
• Practical knowledge of software design quality engineering and IEC 62304.
• Experience developing or implementing QMS processes, procedures, and quality documentation.
• Experience supporting cloud-based software from a quality engineering or software lifecycle perspective.
• Knowledge of computer/software validation, design controls, and medical device change control.
• Understanding of medical device regulations and standards, including ISO 13485 and EU MDR, and familiarity with U.S. and EU regulatory frameworks.
• Understanding of non-medical software product development processes and lifecycle requirements.
• Strong documentation, communication, and cross-functional collaboration skills.
• Ability to explain quality requirements and provide guidance and training to technical teams.

Preferred Qualifications

• Two or more years of medical device industry experience.
• Experience with Software as a Medical Device (SaMD).
• Familiarity with Agile QMS.
• Experience with nonconformances and corrective and preventive actions (NC/CAPA).
• Familiarity with emerging standards and requirements for AI-enabled medical device software.