Principal Quality Engineer
About The Position
The Principal Software Quality Engineer supports the design, development, and lifecycle support of medical device software, including software incorporating artificial intelligence, for new and existing products. This role works closely with design and cross-functional teams to support new product introductions, maintain software design documentation, and ensure compliance with applicable quality, regulatory, and industry standards. The position plays a key role in risk management, verification and validation activities, design reviews, cybersecurity considerations, and implementation of software changes throughout the product lifecycle.
Requirements
- Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or related technical field; advanced degree preferred.
- 5+ years experience in software engineering, including technical leadership for complex product development programs.
- Strong knowledge of IEC 62304 software development lifecycle processes, software design, and change management.
- Familiarity with FDA software-related guidances and expectations.
- Experience working within a quality management system compliant with ISO 13485.
- Understanding of artificial intelligence applications in medical devices, including associated development and regulatory considerations.
- Strong written and verbal communication skills.
- Proven ability to work effectively across cross-functional teams and influence technical decisions.
Nice To Haves
- Familiarity with AAMI TIR97.
- Knowledge of medical device cybersecurity principles and applicable standards, including ANSI/AAMI/UL 81001-5-1.
- Experience supporting cybersecurity-by-design activities for connected or software-enabled medical devices.
Responsibilities
- Partner with design and cross-functional development teams to support software activities for new product introductions.
- Lead or contribute to software architecture, design, implementation, integration, and maintenance for product development projects.
- Maintain software design documentation and ensure it remains current throughout the product lifecycle.
- Support software changes, enhancements, defect corrections, and sustaining engineering activities for released products.
- Lead software risk management activities, including hazard analysis, risk assessments, and implementation of risk controls.
- Support verification and validation planning, protocol development, execution, and documentation.
- Participate in design reviews and provide technical guidance to ensure robust, compliant, and maintainable software solutions.
- Collaborate with quality, regulatory, systems, and test engineering teams to support compliance with internal procedures and external standards.
- Review and approve technical documentation, including software requirements, architecture and design documents, test protocols, traceability matrices, and change records.
- Ensure software development activities align with design controls, software development lifecycle processes, and applicable regulatory expectations.
- Provide technical leadership for complex troubleshooting, root cause investigations, and continuous improvement initiatives.
- Mentor engineers and serve as a technical leader across multiple projects and product platforms.
- Support audit, inspection, and regulatory submission readiness activities as needed.
Benefits
- flexible working environment
- competitive total rewards
- wellness incentives
- culture of recognition and performance awards
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What This Job Offers
Job Type
Full-time
Career Level
Principal
