LanceSoft
Software Quality Engr II - Exempt
LanceSoft, Lafayette, Colorado, United States, 80026
JOB DESCRIPTION
This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities:New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team;Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.Reviews software systems design, change specifications, and plans against contractual and/or process requirements.Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.EDUCATION REQUIRED:Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or QualityNice to HaveExperience in the medical device industryExperience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standardsNavigation systems experience preferredExcellent oral and written communication skills
This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities:New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team;Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.Reviews software systems design, change specifications, and plans against contractual and/or process requirements.Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.EDUCATION REQUIRED:Bachelor's Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or QualityNice to HaveExperience in the medical device industryExperience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standardsNavigation systems experience preferredExcellent oral and written communication skills