Test Engineer – Embedded Systems (Medical Devices) jobs in United States
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Ztek Consulting · 7 hours ago

Test Engineer – Embedded Systems (Medical Devices)

positionBurlington, MA
timeContract
remoteOnsite
senioritySenior Level
money$65/hr - $65/hr
date6+ years exp

Ztek Consulting is seeking an experienced Embedded Software Test Engineer to join their Medical Devices team. In this role, you will be responsible for designing, implementing, and executing tests for embedded software systems in medical devices, ensuring software quality and regulatory compliance.

ConsultingHuman ResourcesInformation TechnologyLegalStaffing Agency
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H1B Sponsor Likelynote

Responsibilities

Create and maintain test documentation in compliance with FDA, IEC 62304, ISO 13485, and other relevant standards
Participate in risk management activities to identify software-related hazards and mitigations
Define test coverage requirements based on software requirements and risk analysis
Design detailed test cases for functional, integration, regression, and system-level testing
Create test specifications that ensure traceability to software requirements
Develop automated test scripts for embedded systems using appropriate test frameworks
Design test environments and fixtures that simulate real-world usage conditions

Qualification

Embedded software testingRegulatory requirements knowledgeSoftware development life cycleTest automationEmbedded software debuggingAnalytical skillsTechnical writingCross-functional teamworkAttention to detailCommunication skillsSelf-motivated

Required

Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field
6+ years of experience in embedded software testing, preferably in medical devices
Strong understanding of software development life cycle and V-model
Knowledge of regulatory requirements for medical device software (FDA, IEC 62304, ISO 13485)
Familiarity with embedded software debugging tools and techniques

Preferred

Strong analytical and problem-solving abilities
Excellent documentation and technical writing skills
Ability to work effectively in cross-functional teams
Attention to detail and commitment to quality
Strong communication skills with both technical and non-technical stakeholders
Self-motivated with the ability to work independently

Company

Ztek Consulting

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Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for its clients.
dateFounded in 2007
location
Duluth, Georgia, USA
people-size201-500 employees
web-link
http://ztek-inc.com

H1B Sponsorship

Ztek Consulting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (1)

Funding

Current Stage
Growth Stage

Leadership Team

S
Shefali Sharma
Founder
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Company data provided by crunchbase