Serve as a Quality representative in the Neuromodulation Software/Firmware product development team, actively engaged in design, testing, and validation of medical device software and firmware within a highly regulated environment, following a hybrid work schedule requiring three days per week onsite.
Responsibilities
- Collaborate with a team of Product Software Quality Assurance Engineers to ensure software quality across development phases.
- Contribute to all stages of Software and Firmware Quality Assurance within a regulated medical device environment.
- Ensure software system quality by validating product requirements, security standards, and regulatory compliance.
- Support full lifecycle software development for Neuromodulation products, from requirements gathering to product retirement.
- Assist in developing and executing Design Validation Plans, test protocols, and reports at the system level, identifying and reporting defects.
- Review and evaluate software and firmware design, development, and testing processes for Neuromodulation product lines.
- Evaluate and approve documentation including user requirements, hazard analyses, risk assessments, usability studies, specifications, test protocols, and traceability matrices.
- Support validation of Automated Test Equipment used in software testing processes.
- Assist in managing software-related Corrective and Preventive Actions (CAPA).
- Participate in Design Validation activities covering user needs, design specifications, code reviews, unit and integration testing, system-level black-box and white-box testing, test automation, exploratory testing, cybersecurity, usability, risk management, FMEAs, and hazard analysis.
Requirements
- Bachelor's degree in Software Engineering, Electrical Engineering, or Biomedical Engineering.
- Minimum of two years of experience in software engineering or software testing.
- At least two years of experience with programming languages such as C#, C++, Swift, Node.js, Java, JavaScript, Cloud platforms, Windows, iOS, Android, Python, or LabView.
- Experience in software risk analysis methodologies.
- Hands-on experience in manual system-level testing of software systems.
Nice to Have
- Master's degree in Computer Science or Software/Electrical Engineering.
- Demonstrated teamwork and interpersonal skills with the ability to collaborate across departments such as R&D, Marketing, Manufacturing, Quality, Regulatory, Clinical, and Project Management.
- Strong attention to detail and commitment to building quality into products from the outset.
- Familiarity with IEC 62304 software development lifecycle standards for medical devices.
Tech Stack
C#, C++, Swift, Node.js, Java, JavaScript, Cloud, Windows, iOS, Android, Python, LabView
Benefits
- Comprehensive benefits package
- Life-work integration support
- Opportunities for community involvement
- Career development and growth
Work Arrangement
Hybrid — requires presence in the Heredia, Costa Rica office at least three days per week, with the option to work remotely on other days.
Team
Member of a team of Product Software Quality Assurance Engineers within the Neuromodulation division.
- Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance
- Collaboration and synergy
- Empowering women
- Supporting the LGBTQ+ community
- Creating opportunities for individuals with disabilities
- Equal opportunity employer
- Gender Equality Policy
Additional Information
- Resumes must be submitted in English.
- The position is based in Heredia, Costa Rica.
- Hybrid work model requires employees to be onsite at least three days per week.
- Requisition ID: 622638
