Position Details

Salary $100K – $200K USD / year

Type Not Specified

Experience entry

Exp. Years 0-1 years

Education Not specified

Category QA & Testing

About this role

This role involves executing software verification activities for medical devices, ensuring compliance with industry standards, and supporting quality assurance processes.

Key Responsibilities

Develop verification plans
Execute test cases
Ensure compliance with standards
Support regulatory audits
Collaborate with cross-functional teams

Technical Overview

The position requires knowledge of software verification, test planning, and regulatory standards such as FDA 21 CFR, ISO 13485, and IEC 62304.

Ideal Candidate

The ideal candidate is an entry-level test engineer with a strong understanding of software verification, test planning, and regulatory standards in the medical device industry.

Must-Have Skills

software verificationtest strategytest planningtest designtest executionregulatory standards

Nice-to-Have Skills

risk managementdesign reviewsverification plans

Tools & Platforms

FDA compliance toolsISO standards toolsIEC standards tools

Required Skills

software verificationtest strategytest planningtest designtest executionregulatory standards

Hard Skills

Software verificationTest strategyTest planningTest designTest executionRegulatory standardsFDA 21 CFRISO 13485IEC 62304Risk managementDesign reviewsVerification plansProtocolsReports

Soft Skills

collaborative teamworkcommunicationattention to detailproblem-solvingregulatory awareness

Industry & Role

Industry Healthcare & Medical

Job Function Perform software verification and validation for medical devices

Role Subtype Test Engineer

Tech Domains Active Directory, Microsoft 365, Azure, Amazon Web Services, Google Cloud Platform, Kubernetes, Docker, Python, Java, SQL / PostgreSQL

Keywords for Your Resume

test engineersoftware verificationtest strategytest planningtest designtest executionregulatory standardsFDA 21 CFRISO 13485IEC 62304risk managementdesign reviewsverification plansprotocolsreportsmedical device testingregulatory compliancequality assurancevalidation

Deal Breakers

Lack of experience with medical device testing standards, No understanding of FDA or ISO standards, Inability to work collaboratively, No attention to detail

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