The Principal Software Quality Engineer is responsible for driving software quality strategy and execution for implantable medical devices, partnering cross-functionally with R&D, systems, and quality teams to ensure software safety, reliability, performance, and regulatory compliance.
What You'll Do
Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V.
Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
Participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
Works within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
Updates and maintains software risk management tools (i.e. Hazard Analysis, FMEAs).
Participates in Cybersecurity related discussions and assists supporting activities including Security Risk Analysis.
Leads and participates in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products.
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Assists in the design and development of software test cases and inspection procedures.
Supports regulatory submissions to notified bodies.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
What We Look For
Bachelor’s degree in mechanical or biomedical engineering or related technical discipline.
8-10 years of experience in a similar medical device engineering role.
Demonstrated experience working with implantable medical devices, including development, testing, validation, or product lifecycle support.
Demonstrated experience in firmware and software engineering.
Experience with software validation, including test planning, protocol execution, defect identification, documentation, and verification of system performance against requirements.
Experience with Issue Tracking Tools and requirements / test management tools.
Understanding of software configuration management (version control, Microsoft office tools)
Adaptable and effective collaborator in a team environment and in self-directed work
Demonstrated use of Quality tools/methodologies
Strong knowledge of Quality System Regulation (QSR), Risk Management standards and software standards (IEC 60601).
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.
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