Job Description

Location: 250 Medtronic Dr Bldg 1 Lafayette COLORADO United States 80026 Duration: 6 months Job Description JOB DESCRIPTION Top 3 technicalskills 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 coveragewith 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. Thisincludes ensuring these documents meet intended use and performance criteria. Quality Assurance and Compliance: Knowledge and experiencein quality assurance practices, especially related to following Quality SystemPractices and meeting FDA, ISO, and European Medical Device standards andregulations, are essential. This includes identifying design-related gaps andimplementing mitigation strategies. Education Required: Bachelor’s Degree in Engineering, Science or technical field Years’ ExperienceRequired : Bachelor’s Degree in Engineering, Science or technical field with2+ years of work experience in Engineering and/or Quality OR Advanced Degree inEngineering, Science or technical field with 0+ years of work experience inEngineering 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 Softwarequality engineers:
• Supports product quality ensuring theimplementation 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 andreports.

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” #J-18808-Ljbffr TAJ Technologies, Inc.

Job Tags

Work experience placement, Immediate start, Remote work,

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