Software Engineer II – Medical Device - DQA & CSV #6626

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 DQA (Design Quality Assurance) & CSV (Computer System Validation) Software Engineer II will support quality and compliance activities during the design and development of product (medical device) software (i.e. SaMD, SiMD), and for process software used in the medical device development, testing, and manufacturing (i.e. CSV).

What you'll do

· Support medical device software teams on IEC 62304 and FDA/ISO 13485 design control deliverables and activities for SaMD (Software as a Medical Device) and SiMD (Software in Medical Device) such as requirements, design, architecture, V&V/test protocols and reports, including the maintenance of DHF (Design History File).

· Support Risk Management deliverables and activities (i.e. Hazard Analysis, Design FMEA, Process FMEA), and the maintenance of the RMF (Risk Management File) in compliance with ISO 14971.

· Support IEC 62366 Usability Engineering activities and documentation.

· Support medical device software Cybersecurity activities and documentation.

· Perform CSV/21 CFR Part 11 and CSA (Computer Software Assurance) activities for software (including off-the-shelf SDLC tools) used in the development, testing, and manufacturing operations of medical devices.

· Develop and maintain validation documentation and 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.

· Update documentation to maintain validated states of computer systems and software.

· Contribute to design and development of medical device software using C/C++, Python, Java, C#.

· Perform medical device software testing and test automation as necessary.

· Drive continuous improvement in validation methodologies, templates, and processes consistent with industry best practices to improve QMS efficiency and audit readiness.

· Use Atlassian/Jira and other SDLC tools to document design controls, validation, traceability, test and defect management, deviation and change control activities.

What you will bring

· 3–5 years of experience in software development, testing, or design controls/assurance 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 IEC 62304, FDA/ISO 13485 Design Controls, GAMP 5, CSV, 21 CFR Part 11, and ISO 13485.

· Experience producing and maintaining high-quality documentation suitable for audits and regulatory submissions.

· Ability to collaborate effectively in cross-functional environments.

· Bilingual English and Spanish

Preferred Qualifications

· Proficiency with C/C++, Python and object-oriented programming in regulated environment.

· Familiarity with scripting languages (Python, MATLAB, shell scripting, PowerShell) to support test automation and tool qualification.

· Experience validating development tools, automated test systems, or cloud-based or hybrid systems used in regulated contexts.

· Experience with software risk hazard analysis and mitigation techniques (e.g., FMEA).

· Knowledge of secure coding, cybersecurity controls, and data integrity principles.

· Background in Agile/Scrum within regulated environments and using Atlassian/Jira and other SDLC tools.

· Ability to support regulatory inspections, audits, and post-market activities including CAPA and complaint 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.

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