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Primary Function of Position
The Senior Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional software development team. This role provides expertise and guidance on software development lifecycle, design controls, risk management, anomaly tracking and code reviews. Additionally, the position ensures the compliance, reliability, and safety of software used in our medical devices.
Essential Job Duties
Software Quality Assurance & Compliance
Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
Participate in design reviews, code reviews, defect tracking and reviews, and software validation activities.
Ensure adherence to software development lifecycle (SDLC) processes, including Agile methodologies.
Risk Management
Support risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1
Collaborate with R&D and testing teams to identify and mitigate software defects.
Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.
Design Control
Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
Partner with engineering to define design inputs, design outputs, and traceability matrices.
Regulatory Support:
Support Regulatory Affairs with creating submissions and responding to submission questions.
Support internal and external audits, including preparation and direct interaction with auditors.
Process Improvement & Cross-Functional Collaboration
Drive continuous improvement in software quality processes and methodologies.
Work closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery.
Implement test automation strategies to improve efficiency and coverage.
Required Skills and Experience
Experience in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.
Experience with risk-based software validation, software test automation, and SDLC processes
Expertise with data modeling and interpretation in areas like field product performance, log analysis, reliability modeling.
Ability to navigate quality systems with minimal oversight on individual projects.
Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
Ability to solve complex problems with minimal oversight.
Ability to articulate complex information to teams, including executive management
Required Education and Training
Requires a minimum of 8 years of related experience with a University Degree (in computer science, software/biomedical/systems/electrical/mechanical engineering, math or physics) or 5 years of relevant experience and an Advanced Degree (in above disciplines)
At least 2 years in a regulated industry is preferred
Preferred Skills and Experience
Preferred experience in AI/ML-based medical software (SaMD/embedded AI).
Knowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA).
Employment type
Full-time
Work arrangement
Hybrid
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