Overview
On Site
USD 95,500.00 - 115,200.00 per year
Full Time
Skills
Manufacturing
Product development
Software development
Programming languages
Software packaging
Minitab
Software design
Verification and validation
Computer science
Software engineering
Biomedical engineering
ISO 13485
ISO 9000
Quality assurance
Metrics
FMEA
Medical devices
Design controls
Design
Software development methodology
Test methods
Automated testing
Job Details
Position Description:
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 and SDLC (Software Development Life Cycle) including complex government and industry regulations including FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304. Understand and work with various programming languages. Utilize software packages to include Minitab. Define and implement software quality metrics to track software progress and quality throughout the development process, implement software risk and reliability tools including Software Failure Mode Effect Analysis (SW dFMEAs) and practices that effectively support software requirements for product software design, integration and verification, validation, and prediction. Review, analyze, and disposition Software Defects or Software Problem Reports (SPRs). Coordinate numerous software validation processes, Medical Device Design Controls, Design History File, and Product Life Cycle. Understand process of software validation, Test Methods Development, Automation testing, and Verification and Validation (V&V) of product software. *Position works a hybrid model and will be onsite in Lafayette, CO location - 3 days per week. ** Relocation assistance not available for this position. #LI-DNI.
Basic Qualifications:
Masters' Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and one (1) year of experience as a Software Quality Engineer or Software Engineer OR Bachelors' Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and two (2) years of experience as a Software Quality Engineer or Software Engineer. Must possess a minimum of one (1) year of experience with each of the following: FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304; Defining and implementing software quality metrics; SW dFMEA; Product software requirements; Software Problem Reports or Software Defects; Medical Device Design Controls, Design History File, and SDLC; and Test Methods Development, Automation testing, and V&V of Product software.
Salary: $95,500 to $115,200 per year
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 and SDLC (Software Development Life Cycle) including complex government and industry regulations including FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304. Understand and work with various programming languages. Utilize software packages to include Minitab. Define and implement software quality metrics to track software progress and quality throughout the development process, implement software risk and reliability tools including Software Failure Mode Effect Analysis (SW dFMEAs) and practices that effectively support software requirements for product software design, integration and verification, validation, and prediction. Review, analyze, and disposition Software Defects or Software Problem Reports (SPRs). Coordinate numerous software validation processes, Medical Device Design Controls, Design History File, and Product Life Cycle. Understand process of software validation, Test Methods Development, Automation testing, and Verification and Validation (V&V) of product software. *Position works a hybrid model and will be onsite in Lafayette, CO location - 3 days per week. ** Relocation assistance not available for this position. #LI-DNI.
Basic Qualifications:
Masters' Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and one (1) year of experience as a Software Quality Engineer or Software Engineer OR Bachelors' Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and two (2) years of experience as a Software Quality Engineer or Software Engineer. Must possess a minimum of one (1) year of experience with each of the following: FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304; Defining and implementing software quality metrics; SW dFMEA; Product software requirements; Software Problem Reports or Software Defects; Medical Device Design Controls, Design History File, and SDLC; and Test Methods Development, Automation testing, and V&V of Product software.
Salary: $95,500 to $115,200 per year
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