Boston Scientific is seeking a Software Design Assurance Engineer III to support new product development and sustaining projects, acting as a quality representative on cross-functional teams to ensure product quality and compliance within the medical device industry.
Requirements
- 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)
- Demonstrated use of Quality tools/methodologies
- Experience with Software integration with electro-mechanical devices
- Understanding of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
Responsibilities
- Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, and software design V&V
- Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
- Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
- Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
- Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs).
- Lead and participate in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products.
Other
- Bachelor’s degree in Engineering, or related discipline
- A minimum of 3 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience or 2 years of experience with an advanced relevant degree
- 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
