Software Quality Engr II

Location: 250 Medtronic Dr Bldg 1 Lafayette COLORADO United States 80026

Duration: 6 months

JOB DESCRIPTION

Top 3 technical skills that are required for the role:

Requirements Analysis and Management:
This skill is crucialfor evaluating product definition requirements, ensuring that software productrequirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design outputs.

Software Documentation and Specification:
The ability toreview and remediate design output documentation, such as software architecturedocumentation and software form and behavior specifications, is key. This includes ensuring these documents meet intended use and performance criteria.

Quality Assurance and Compliance:
Knowledge and experience in quality assurance practices, especially related to following Quality System Practices and meeting FDA, ISO, and European Medical Device standards and regulations, are essential. This includes identifying design-related gaps and implementing mitigation strategies.

Education Required:Bachelor’s Degree in Engineering, Science or technical field

Years’ Experience Required
:
Bachelor’s Degree in Engineering, Science or technical field with2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

Will the contractorbe working 40 hours a week? Yes 40 hours a week

Does this positionrequire the candidate to be onsite or remote
:
Onsite

What is your timelinefor scheduling interviews? As soon as possible.

What product linewill this person support? Stealth Station in Navigation business unit.

· This position has the opportunities to work withcorss-functional team members to support Post Market Software relatedactivities:

· Post Market Release lifecycle, such asremediation, CAPA, and other activities as assigned.

· Responsibilities may include but not limited tothe 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 systemsactivities including requirements, design, development, documentation,integration, test, verification and validation.

· Ensures that projects and process controldocumentation are compliant with requirements, objectives and/or contracts.

· Reviews software systems design, changespecifications, and plans against process requirements.

· Collaborate with test engineering onverification and validation strategies, review and approve test protocols and reports.

Nice to Have

· Experience in the medical device industry

· Experience with FDA Quality System Regulations,Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards

· Navigation systems experience preferred

· Excellent oral and written communication skills

“TAJ Technologies, Inc. is an EEO/AA

Employer:

women, minorities, the disabled and veterans are encouraged to apply”