Boston Scientific
Software Design Assurance Engineer I
Boston Scientific, Osseo, Minnesota, United States, 55311
Software Design Assurance Engineer I
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About The Role
The Design Assurance Engineer I will interface with R&D and other supporting cross functional teams on development and maintenance of medical equipment with specific focus on software and cybersecurity elements. Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process and supports software applications throughout the Software Development Lifecycle (SDLC) per IEC 62304 or equivalent standard. Implementation of risk management as well as software design processes with compliance to company procedures including quality plans, risk management plans and reports, hazard analysis, product risk management workbook (design FMEA and software FMEA), verification & validation protocols/testing/reports, software bug investigations and resolutions. Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality related issues. Actively participate in all aspects of Design Control including systems and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your Responsibilities Include:
Participates in the implementation of software design assurance: Risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design verification and validation, Design/Software Change Analysis Forms, Risk Change Analysis forms etc. Exercises understanding of software tools and technologies incorporated into design with thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition software bugs and software related field issues. Follows software application development procedures and participates in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principles in robust design and in design for manufacturability. Assists in design, develop, refine, and validation of device software test methods and inspection procedures. Guides/authors software design verification and design validation protocols and reports. Fully supports the Quality System by building quality into all aspects of the incumbent's work and to ensure compliance with corporate quality systems and software requirements, including non-functional requirements. Identifies and implements effective process control systems to support the software development, software tool validation, qualification, and on-going manufacturing of software and electronic products to meet or exceed internal and external standards or regulations. May develop technical solutions to complex problems and apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination. 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're Looking For:
Required qualifications: Bachelor's degree in computer science engineering, or related discipline Minimum of 1 year of experience in design assurance, quality, new product development, or related medical device/regulated industry Understanding of Software Development Lifecycle (SDLC) Understanding of software testing and issue investigation/resolution Understanding of software configuration management?(version control, Microsoft office tools) Knowledge of analytical techniques, problem solving and process improvement Strong written/verbal communication skills Preferred qualifications: Prior Software Design Assurance or related experience is a plus 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 with Software code reviews Experience with Issue Tracking Tools (Jira) and Requirements/Test Management Tools Knowledge of Cyber security and Cloud Computing concepts Knowledge of Artificial Intelligence / Machine Learning concepts
Work mode: Hybrid Onsite Location(s): Maple Grove, MN, US, 55311 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About The Role
The Design Assurance Engineer I will interface with R&D and other supporting cross functional teams on development and maintenance of medical equipment with specific focus on software and cybersecurity elements. Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process and supports software applications throughout the Software Development Lifecycle (SDLC) per IEC 62304 or equivalent standard. Implementation of risk management as well as software design processes with compliance to company procedures including quality plans, risk management plans and reports, hazard analysis, product risk management workbook (design FMEA and software FMEA), verification & validation protocols/testing/reports, software bug investigations and resolutions. Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality related issues. Actively participate in all aspects of Design Control including systems and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Relocation assistance is available for this position. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your Responsibilities Include:
Participates in the implementation of software design assurance: Risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design verification and validation, Design/Software Change Analysis Forms, Risk Change Analysis forms etc. Exercises understanding of software tools and technologies incorporated into design with thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition software bugs and software related field issues. Follows software application development procedures and participates in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principles in robust design and in design for manufacturability. Assists in design, develop, refine, and validation of device software test methods and inspection procedures. Guides/authors software design verification and design validation protocols and reports. Fully supports the Quality System by building quality into all aspects of the incumbent's work and to ensure compliance with corporate quality systems and software requirements, including non-functional requirements. Identifies and implements effective process control systems to support the software development, software tool validation, qualification, and on-going manufacturing of software and electronic products to meet or exceed internal and external standards or regulations. May develop technical solutions to complex problems and apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination. 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're Looking For:
Required qualifications: Bachelor's degree in computer science engineering, or related discipline Minimum of 1 year of experience in design assurance, quality, new product development, or related medical device/regulated industry Understanding of Software Development Lifecycle (SDLC) Understanding of software testing and issue investigation/resolution Understanding of software configuration management?(version control, Microsoft office tools) Knowledge of analytical techniques, problem solving and process improvement Strong written/verbal communication skills Preferred qualifications: Prior Software Design Assurance or related experience is a plus 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 with Software code reviews Experience with Issue Tracking Tools (Jira) and Requirements/Test Management Tools Knowledge of Cyber security and Cloud Computing concepts Knowledge of Artificial Intelligence / Machine Learning concepts