Senior Software Design Assurance Engineer

Boston Scientific•Arden Hills, MN

About The Position

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. 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). Participate in Cybersecurity related discussions and assist supporting activities including Security Risk Analysis. 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. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Assist in the design and development of software test cases and inspection procedures. Support 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.

Requirements

Bachelor's degree in engineering, or related discipline related field of study
A minimum of 5 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

Nice To Haves

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

Responsibilities

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.
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).
Participate in Cybersecurity related discussions and assist supporting activities including Security Risk Analysis.
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.
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Assist in the design and development of software test cases and inspection procedures.
Support 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.