Senior Software DQA Engineer - Medical Device

About The Role

Develops, modifies, applies, and maintains standards for Software Quality methods, processes and procedures to meet internal and external regulatory requirements. Provides expertise and conducts evaluation of software systems validation activities including requirements, design, development, integration, test, verification, and implementation. Establishes methods for monitoring the compliance of software system processes, standards, and procedures. Coaches less experienced colleagues and executes on projects along with other members of the team.

Role includes AI/IT/clinical/manufacturing/Quality software and computerized system validation and maintenance. Role requires expertise in software validation as it applies to both Waterfall and an Agile environment.

• Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain AI/IT/clinical/manufacturing/quality software.
• Acts as a subject matter expert on software validation to guide, coach, and train project teams on effective and efficient implementation of software validation processes.
• Demonstrates mastery of the software validation processes.
• Possesses a fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements.
• Works with management to understand priorities and plans, and provides input to resource and time allocation accordingly.
• Plays key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables, and demonstrates the ability to lead, acknowledge, develop, communicate, and implement a validation strategy to ensure compliance.
• Guides implementation of enterprise systems solutions through planning, system integration, and verification and validation activities.
• Proactively involves in continuous improvement activities while ensuring software systems are defensible for regulatory requirements.
• Contributes to the development, review, and/or approval of SOPs and supporting Work Instructions.
• Demonstrates expertise to effectively communicate within all levels of the organization around concepts of Software verification and validation activities.
• Communicates the value of the Software Quality process or cross‑functional software validation initiatives, ensuring buy‑in from project team members to the disciplines, decisions, and practices of Software Validation.
• Provides structured Quality Assurance activities and metrics to promote efficient and cost‑effective operations.

• Bachelor’s degree (or higher) in Engineering or related fields.
• 8+ years of related experience, including 3+ years’ experience in Software Quality and validation.
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices, IEC 62304 Software, and Design Verification.
• Good understanding of quality system requirements and how each quality system element connects.
• Some experience in working with Agile software development and validation methodologies.
• Some experience or knowledge of work management and testing tools (such as JIRA, Xray, qTest).
• Some experience with AI applications.
• Experience working with a diverse population of internal and external customers.
• Comfortable speaking and presenting to leadership.
• Strong written and verbal communication skills.
• Creative and innovative thinking skills.
• Experience managing projects and project deliverables to completion.
• Comfortable working independently and as part of a cross‑functional team.
• Ability to manage multiple priorities and work without ambiguity.

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.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.