Software Engineer II Medical Device

Brief Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

The Software Engineer II will focus on Computer System Validation (CSV), software quality, and compliance activities within the development of regulated medical device software. This role requires strong technical skills in C++ and phyton environments, combined with hands-on experience implementing and maintaining validation processes aligned with FDA and international regulatory expectations. The engineer will contribute to software development and validation while ensuring that all software artifacts, tools, and processes meet requirements defined under 21 CFR Part 11, ISO 13485, IEC 62304, and related quality system regulations.

What You'll Do

Perform Computer System Validation (CSV) activities for software used in the development, testing, and operation of medical devices, ensuring compliance with 21 CFR Part 11 and applicable guidelines. Develop, document, and maintain validation deliverables including URS, FRS, risk assessments, IQ/OQ/PQ, traceability matrices, and validation reports. Support the creation and execution of verification and validation (V&V) plans, including test protocols, test automation, and defect investigations. Contribute to design and development of medical device software using C++, Linux, Qt, and OpenGL, ensuring alignment with IEC 62304 software lifecycle requirements. Ensure compliance with ISO 13485 design controls, including requirement management, architecture documentation, and risk mitigation (per ISO 14971). Work closely with Quality, Regulatory, and Systems Engineering to interpret compliance requirements and translate them into actionable engineering tasks. Participate in software tool qualification activities and maintain validation for critical development tools per FDA and ISO 13485 requirements. Assist with audits, CAPAs, and documentation updates to maintain validated states of systems and software. Support continuous improvement in validation methodologies, templates, and processes to increase efficiency and audit readiness. Use Jira and related tools to document validation activities, defects, deviations, and change control actions.

What You Will Bring

3–5 years of experience in software engineering or software quality roles within the medical device or other regulated industry. Bachelor’s or Master’s degree in Computer Science, Software Engineering, Electrical Engineering, or related field. Strong hands-on experience with CSV activities including requirements documentation, test development, execution, and reporting. Working knowledge of 21 CFR Part 11, GAMP 5, ISO 13485, and IEC 62304. Proficiency with C++ and object-oriented programming. Experience producing high-quality documentation suitable for audits and regulatory submissions. Ability to collaborate effectively in cross-functional environments. Bilingual English and Spanish

Preferred Qualifications

Experience validating development tools, automated test systems, or cloud-based or hybrid systems used in regulated contexts. Familiarity with scripting languages (Python, MATLAB, shell scripting, PowerShell) to support test automation and tool qualification. Experience with software risk analysis and hazard mitigation (e.g., FMEA, fault-tree analysis). Knowledge of secure coding, cybersecurity controls, and data integrity principles relevant to 21 CFR Part 11 compliance. Familiarity with network protocols (TCP/IP, HTTP, OpenSSL) and data handling in validated environments. Experience with GUI development, 2D/3D visualization, or graphics pipelines using Qt, GLSL, OpenCL (for teams integrating validation with real-time graphics systems). Background in Agile/Scrum within regulated environments and experience tracking validation tasks in Jira. Ability to support audits, inspections, and post-market activities including CAPA investigations.

ECI is an equal opportunity employer

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.