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VERIFICATION & VALIDATION ENGINEER

Date Posted: 4/12/2021

JOB DESCRIPTION

Spectral MD, Inc.

Position Title: Verification & Validation Engineer

About Spectral MD, Inc.

 

Spectral MD, Inc. is an uptown Dallas based medical tech company that answers clinical questions through the development of data pipelines, artificial intelligence (“AI”) algorithms and proprietary optical technology. Spectral MD Inc.’s DeepView® Wound Imaging System (“DeepView®”) is an advanced medical device that uses a digital approach to deliver images of blood flow under the skin's surface to look deep into the body without ever touching the patient. Our mission is to provide physicians with the ability to accurately assess perfusion and wound healing potential for patients suffering from burn wounds and peripheral artery disease. We are scientists, engineers, and forward-thinkers striving to modernize the management of wound care.  

Position Overview:

Spectral MD, Inc. is seeking a highly motivated Verification and Validation Engineer with experience developing Class II or Class III medical devices and at least five years in the medical device industry. The Verification and Validation (V&V) of Spectral MD, Inc. medical device(s) includes, but is not limited to, defining, planning, documenting, leading, and/or performing all V&V activities.

Primary Duties / Responsibilities:

  • Define, plan and lead activities, including, test method development and validation, fixture design and testing optimization in support of Design Verification and Validation.

  • Evaluate and analyze the system (entire Device and any peripherals) performance and reliability to ensure the design is adequately pressure-tested to satisfy user, regulatory and business requirements. 

  • Understand the system and subsystem design performance to identify and address early in the development process any potential design integration and design transfer risks.

  • Create and document test methodologies and provide feedback and recommendations for product/design changes.

  • Follow the Design Control Process and Ensure compliance with SMD’s quality policies, procedures, and practices.

  • Develop, document, and verify/validate test tools and test methodology for the verification of hardware (electrical, mechanical, imaging). 

  • Write and execute integration, plans, protocols, and associated reports.

  • Write and execute characterization, plans, protocols, and associated reports.

  • Write and execute verification plans, protocols, and associated reports.

  • Write validation plans, protocols and execute validation testing to demonstrate coverage of user needs and intended uses.

  • Analyze information and test data to support technical solutions.

  • Identify, report, and track defects identified throughout all phases of the development lifecycle.

  • All other duties assigned. 

Qualifications:

Required Education and Experience:

  • Experience developing Class II and/or Class III medical devices. 

  • A Bachelor’s degree, or an advanced degree, in engineering, biotech, life sciences; or equivalent experience. 

  • A minimum of five years’ experience in the medical device industry. 

  • Working knowledge of following regulations/standards:   

    • 21 CFR 820 and ISO 13485  

    • EU MDD (EU MDD 93/42 EEC), EU MDR 

    • Risk Management per ISO 14971 

  • Experience working in cross functional organization.

  • Knowledge of the Microsoft office suite of products (PowerPoint, Excel, etc.,)

Knowledge, Skills, and Abilities:

  • Highly detail-oriented, excellent analytical and troubleshooting skills, highly motivated team player adept at cross-functional interaction.

  • Excellent verbal and written communication skills. 

  • Excellent interpersonal and customer service skills.

  • Excellent organizational skills and attention to detail.

  • Excellent time management skills with a proven ability to meet deadlines.

  • Strong analytical and problem-solving skills.

  • Ability to prioritize tasks and to delegate them when appropriate.

  • Proficient with Microsoft Office Suite or related software.

Physical Requirements:

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Prolonged periods of sitting at a desk and working on a computer

  • Must be able to lift, up to 25 pounds at times

 

Travel:

25% of travel time expected for the position, overnight to clinics or vendors.

 

Spectral MD, Inc. is an equal opportunity employer and participates in E-Verify. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other characteristic protected by applicable federal, state, or local laws.

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