eTeam
Job Description: Software Test Engineer
Client Specific Location: Plymouth, MN
100% work from office
We are seeking a detail-oriented and experienced Manual Testing Engineer to join our team, specializing in the medical domain. The ideal candidate will have hands-on experience in validating healthcare applications, with a strong understanding of NPS (Non-Product Software) validation protocols and compliance standards. You will be responsible for validating the NPS tools, coordinating with the stake holders and offshore team, formal documentation, protocol creation and execution, requirement traceability.
Key Responsibilities:
Perform manual testing of Non-Product Software (NPS) used in medical device environments (e.g., document management systems, ERP, LIMS, MES). Develop and execute test plans, test cases, and validation protocols in accordance with regulatory and quality requirements. Conduct NPS validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure traceability of requirements through RTM (Requirement Traceability Matrix). Collaborate with QA, IT, and business stakeholders to ensure software meets intended use and compliance standards. Document and manage defects using tools like JIRA, HP ALM, or similar. Support audits and inspections by providing validation documentation and evidence. Maintain detailed records of testing activities and validation deliverables.
Required Skills & Qualifications:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 5+ years of experience in manual testing within the medical device or healthcare domain. Experience in NPS validation and understanding of software validation lifecycle. Strong documentation and communication skills. Ability to work independently in an onsite setup and coordinate with cross-functional teams.
Preferred Qualifications:
Experience with quality systems software (e.g., TrackWise, MasterControl, SAP). Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485. ISTQB or equivalent QA certification. Exposure to risk-based validation approaches.
We are seeking a detail-oriented and experienced Manual Testing Engineer to join our team, specializing in the medical domain. The ideal candidate will have hands-on experience in validating healthcare applications, with a strong understanding of NPS (Non-Product Software) validation protocols and compliance standards. You will be responsible for validating the NPS tools, coordinating with the stake holders and offshore team, formal documentation, protocol creation and execution, requirement traceability.
Key Responsibilities:
Perform manual testing of Non-Product Software (NPS) used in medical device environments (e.g., document management systems, ERP, LIMS, MES). Develop and execute test plans, test cases, and validation protocols in accordance with regulatory and quality requirements. Conduct NPS validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Ensure traceability of requirements through RTM (Requirement Traceability Matrix). Collaborate with QA, IT, and business stakeholders to ensure software meets intended use and compliance standards. Document and manage defects using tools like JIRA, HP ALM, or similar. Support audits and inspections by providing validation documentation and evidence. Maintain detailed records of testing activities and validation deliverables.
Required Skills & Qualifications:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 5+ years of experience in manual testing within the medical device or healthcare domain. Experience in NPS validation and understanding of software validation lifecycle. Strong documentation and communication skills. Ability to work independently in an onsite setup and coordinate with cross-functional teams.
Preferred Qualifications:
Experience with quality systems software (e.g., TrackWise, MasterControl, SAP). Knowledge of FDA 21 CFR Part 11, ISO 14971, and ISO 13485. ISTQB or equivalent QA certification. Exposure to risk-based validation approaches.