Software Test Engineer

Brooksource

Lafayette (CO)

On-site

USD 48,216 - 61,992

Full time

14 days+

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Benefits offered by this job

Comprehensive benefits (health, vision, dental)

Paid holidays

Sick time accrual

Job summary

A leading medical device company is looking for a Software/System Test Engineer in Lafayette, CO. This role focuses on performing verification and validation for cutting-edge medical products in a dynamic regulatory environment. Applicants should have a BS/BA in Engineering and familiarity with AAMI, ISO, and FDA standards, along with experience in software validation and regulatory practices. Competitive hourly pay and potential long-term contract options are included for the right candidate.

Qualifications

BS/BA in Engineering or relevant field required.
Knowledge of applicable AAMI, ISO, FDA standards needed.
Experience in a regulatory environment, particularly medical devices.

Responsibilities

Create verification and validation activities for medical products.
Design test equipment and tools, analyze data for needed changes.
Coordinate testing at external facilities.

Skills

Regulatory experience with AAMI, ISO, FDA standards

Software design and development practices

Validation experience in software

Teamwork ability

Problem-solving skills

Education

BS/BA in Engineering or relevant degree

Tools

Test automation frameworks

Mathematical/statistical methods

Job description

This range is provided by Brooksource. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $45.00/hr

Direct message the job poster from Brooksource

Job title: Software/System Test Engineer

Company: Major Medical Device Company

Work Model: 5 Days on Site (Lafayette, CO)

Engagement: Long-term W2 Contract (Potential for extension and/or FTE conversion)

Rate: $35-45/hr. (DOE)

As a Brooksource consultant working directly with our client, you will be a W2 employee with full-time 40 hour work week. Comprehensive benefits (health, vision, dental), paid holidays, & sick time accrual is available to all employees on contract.

About Our Client:

Together, we can change healthcare worldwide. At Med. Device Client, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

The Role

This position has the responsibility and authority to create and perform verification & validation activities for software and systems to ensure Medtronic’s cutting-edge medical products meet our user’s needs and our quality and reliability standards. This position requires application of technical expertise to determine and develop approaches to solve complex technical problems with ingenuity and creativity. Work is performed under general direction.

Responsibilities

Plan, schedule, and design test equipment, tools, and fixtures.
Analyze data and define changes needed in test equipment, procedures, and processes.
Apply technical standards and principles to testing activities.
Verify and validate new or modified products, creating plans, protocols, and reports.
Develop and maintain test software and ensure test equipment is calibrated and functional.
Coordinate testing at external facilities and manage test tracking and data systems.
Troubleshoot, analyze defects, implement process improvements, and communicate findings to teams.

Requirements

Academics: BS/BA in Engineering or relevant degree
Regulatory Experience: Knowledge of applicable AAMI, ISO, FDA and EN standards
Working knowledge of software design, development, debug and test practices.
Validation experience (ideally within context of software)
Extensive experience working in a regulatory environment
Particularly experience with medical device testing and understanding of FDA Quality System Regulations (QSR)
Oral and written communication skills.
Ability to work in a team environment.

Nice to Have

Able to handle multiple tasks/projects and manage priorities
Experience with test automation including GUI, integration and stress testing and designing and implementing test automation frameworks.
Project management skills including planning, estimation, tracking and communication
Self-motivated with strong problem-solving skills and the ability to work independently
Knowledge of statistical methods.

Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.

Seniority level

Mid-Senior level

Employment type

Contract

Job function