Principal Reliability Engineer – Software Quality

Medtronic • Boston, MA

18h • $140,600 - $198,000 • Hybrid

About The Position

Responsible for various software quality assurance functions during the Product Development Process (PDP) development lifecycle of complex medical devices to identify software problems and their causes in partnership with Software Developers and Testers. Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices. Coordinate Medical Device Product Development (MDPD) and SDLC (Software Development Life Cycle) including navigating complex government and industry regulations including FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304. Utilize the Association for the Advancement of Medical Instrumentation (AAMI TIR45) to understand and work with various programming languages including C, C++, C#, Python and SQL. Utilize Minitab software packages for statistical analysis, process improvement, and quality control. Define and implement software quality metrics for tracking software progress and quality throughout the development process. Leverage reliability tools including Software Failure Mode Effect Analysis and Software Fault Tree Analysis (SFMEAs and SFTAs). Leverage practices that effectively support software requirements for product software design, integration and verification, validation, and prediction. Review, analyze and disposition Software Defects and Software Problem Reports (SPRs). Coordinate software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle. Responsible for software validation, test methods development, automation testing, verification and validation (V&V) of product software.

Requirements

• Bachelors’ Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and seven (7) years of experience as a software engineer or related occupation in software engineering or Master’s Degree in Information Technology, Computer Science, Software Engineering or related technical or engineering field and five (5) years of experience as a software engineer or related occupation engineering.
• Coordination of cross functional groups for quality objectives around product software, quality system , and software technologies for medical devices
• MDPD, SDLC, FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304
• AAMI TIR45, C, C++, C#, Python and SQL
• Minitab
• SFMEA and SFTA
• Review, analyze, and disposition of Software Defects and Software Problem Reports (SPRs)
• Software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle
• Software validation, Test Methods Development, Automation testing, & V&V of product software.

Responsibilities

• Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices.
• Coordinate Medical Device Product Development (MDPD) and SDLC (Software Development Life Cycle) including navigating complex government and industry regulations including FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304.
• Define and implement software quality metrics for tracking software progress and quality throughout the development process.
• Leverage reliability tools including Software Failure Mode Effect Analysis and Software Fault Tree Analysis (SFMEAs and SFTAs).
• Leverage practices that effectively support software requirements for product software design, integration and verification, validation, and prediction.
• Review, analyze and disposition Software Defects and Software Problem Reports (SPRs).
• Coordinate software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle.
• Responsible for software validation, test methods development, automation testing, verification and validation (V&V) of product software.

Benefits

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal