Principal Software Quality Engineer - Medical Device

About The Role

This is an exciting opportunity for a software focused Principal Software Quality Engineer supporting a cross-functional team on development and maintenance of Implantable and external devices and software. The role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, run the business, and regulatory and standards compliance.

• 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.

• Bachelor’s degree in mechanical or biomedical engineering or related technical discipline
• A minimum of 9 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Understanding of Software Development Life Cycle (SDLC)
• Experience with software testing and issue investigation/resolution
• 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
• Strong communication skills (verbal & written)
• Ability to work in a highly matrixed and geographically diverse business environment
• Demonstrated use of Quality tools/methodologies
• Prior Software Design Assurance experience
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
• Experience in conducting and participating in code reviews

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.