Principal Reliability Engineer – Software Quality

Medtronic•Boston, MA

8h•Hybrid

About The Position

Principal Reliability Engineer- Software Quality for Covidien, LP. 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 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 in software engineering.
At least five (5) years of experience with coordination of cross functional groups for quality objectives around product software, quality system, and software technologies for medical devices.
At least five (5) years of experience with MDPD, SDLC, FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, and IEC 62304.
At least five (5) years of experience with AAMI TIR45, C, C++, C#, Python and SQL.
At least five (5) years of experience with Minitab.
At least five (5) years of experience with SFMEA and SFTA.
At least five (5) years of experience with review, analysis, and disposition of Software Defects and Software Problem Reports (SPRs).
At least five (5) years of experience with software validation processes including Software Cybersecurity, Medical Device Design Controls, Design History File and Product Life Cycle.
At least five (5) years of experience with software validation, Test Methods Development, Automation testing, & V&V of product software.

Responsibilities

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.
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
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Medtronic Employee Referral Bonus Program ($1,000)