What are the responsibilities and job description for the Quality Engineer II (Medical Device) position at ATR International?
Job Title: Software Quality Engr II
Type: Contract - Job Title: Software Quality Engineer II (Medical Device)
Type: Contract- 6 Months
Day Shift
Location:250 Medtronic Dr Bldg 1, Lafayette, CO
Pay: Can Be Flexible
What product line will this person support? Stealth Station in Navigation business unit.
We are seeking a Software Quality Engr II for a very important client.
This position has the opportunities to work with corss-functional team members to support Post Market Software related activities:
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 process requirements.
Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.
The ideal candidate must possess the following qualifications:
Top 3 technical skills that are required for the role:
Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design outputs.
Software Documentation and Specification: The ability to review and remediate design output documentation, such as software architecture documentation 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.
Years’ Experience Required: Bachelor’s Degree in Engineering, Science or technical field with 2 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.
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
Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county
