Position SummaryWe are seeking an experienced
Software Engineer in Test to join our Software team and support the development of innovative implantable medical device technologies. This role is responsible for designing, developing, and executing software verification strategies for implantable devices and their supporting applications.
The ideal candidate combines strong software testing expertise with a passion for automation, quality, and continuous improvement. Working closely with Software, Systems, Quality, Regulatory, and Hardware teams, you will help ensure the delivery of safe, reliable, and compliant products that improve patients' lives.
Essential Duties and Responsibilities- Design, develop, execute, and maintain software verification activities throughout the software development lifecycle.
- Analyze software and system requirements to develop comprehensive verification strategies, test plans, and test procedures.
- Create and maintain manual and automated test cases for embedded software, desktop applications, and mobile applications.
- Design and implement Python-based automated test frameworks for functional, integration, regression, and system-level testing.
- Perform software integration testing involving implantable devices, external programmers, patient controllers, and related accessories.
- Investigate software defects, analyze logs, reproduce issues, and collaborate with development teams to resolve problems.
- Participate in software design reviews, risk analysis activities, verification planning, and product release efforts.
- Ensure software verification documentation complies with quality system and regulatory requirements.
- Maintain traceability between requirements, risk controls, test cases, and verification evidence.
- Support root cause investigations and corrective actions for software-related issues.
- Mentor junior engineers and promote software quality best practices.
- Contribute to the continuous improvement of test automation, verification processes, and development workflows.
Required Qualifications- Bachelor's or Master's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related discipline.
- 3+ years of experience in software testing, software verification, or software quality engineering.
- Experience testing embedded systems or medical device software.
- Strong programming skills in Python.
- Experience developing automated test frameworks and reusable test libraries.
- Understanding of object-oriented programming principles.
- Experience working within Agile development environments.
- Strong analytical, troubleshooting, debugging, and problem-solving skills.
- Excellent written and verbal communication skills.
Preferred Qualifications- Experience with implantable medical devices or neuromodulation systems.
- Knowledge of IEC 62304 software lifecycle processes.
- Familiarity with FDA Quality System Regulation (21 CFR Part 820) and ISO 13485.
- Experience with software risk management in accordance with ISO 14971.
- Experience using requirements management tools such as Jama.
- Experience using defect tracking systems such as Jira.
- Experience with Git, Jenkins, and CI/CD pipelines.
- Experience working with hardware communication interfaces such as UART, USB, SPI, I2C, or Bluetooth Low Energy (BLE).
- Familiarity with laboratory equipment such as oscilloscopes, logic analyzers, function generators, and power supplies.
- Experience working within Windows and Linux environments.
- Experience validating desktop, mobile, and embedded applications.
Technical SkillsProgramming Languages- Python (Required)
- C# (Preferred)
Test Automation Tools- PyTest
- Robot Framework
- Selenium
- Appium
Development & Configuration ToolsRequirements & Test ManagementMedical Device Standards- IEC 62304
- ISO 13485
- ISO 14971
- FDA Design Controls
- Good Documentation Practices (GDP)
Desired Competencies- Strong ownership and accountability.
- Excellent troubleshooting and root cause analysis skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong collaboration and communication skills.
- Passion for automation and continuous improvement.
- Ability to mentor and support other engineers.
- Strong attention to detail and commitment to product quality.
Work Environment- Office and laboratory-based engineering environment.
- Frequent collaboration with Software, Systems, Hardware, Quality, Regulatory, and Manufacturing teams.
- Participation in medical device development activities from concept through product release.
- Fast-paced environment supporting multiple concurrent projects.
Physical Requirements- Ability to remain in a stationary position while working at a computer for extended periods.
- Ability to operate computer systems, laboratory equipment, and test devices.
- Ability to communicate effectively with cross-functional teams and stakeholders.
- Ability to occasionally move throughout office, laboratory, and manufacturing environments.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.
