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Defibtech, LLC · 18 hours ago

Validation Engineer II

Guilford, CT

Full-time

Hybrid

New Grad, Entry Level

0+ years exp

Defibtech is a company focused on developing next-generation medical devices, and they are seeking a Validation Engineer II to support the release of these products. The role involves planning, designing, and implementing validation strategies, as well as developing test protocols and ensuring compliance with regulatory standards.

Health CareManufacturingMedicalMedical Device

Culture & Values

Responsibilities

Supports the development of validation plans for medical device design functions (software, electrical and mechanical), defines appropriate test methods and apply statistical methods to identify sample sizes

Develops and executes validation protocols based on system requirements and approved procedures and standards (ISO and FDA)

Collates, analyzes, summarizes, and interprets validation protocol results into cohesive reporting for FDA and CE Mark approvals

Properly documents activities in accordance with best engineering practices, company procedures, and regulatory requirements

Participates in Design Reviews and provides verification support to development teams (e.g., Code Reviews, Software Module and System testing, test automation, testing procedures)

Designs test equipment, test fixtures, and testing software for diagnosis of medical devices

Demonstrates Defibtech’s values on the job by focusing actions on Integrity, Passion, Ownership, and Innovation. Promotes and participates in continuous improvement

Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations, and applicable statutes)

Qualification

Validation protocolsDesign verificationStatistical methodsEngineering design standardsTechnical writingAnalytical skillsProblem-solvingCommunication skillsOrganizational skillsTeamwork

Required

Bachelor's degree and 0-2 years of related experience or the equivalent combination of education, experience, and training

Strong analytical and problem-solving ability

Strong technical writing ability for design validations and reports

Strong written and oral communication skills to accurately convey issues and information

Strong organizational skills and attention to detail

Ability to support multiple projects concurrently while maintaining quality and meeting deadlines

Ability to work independently and with a team

Preferred

Bachelor's degree in a science-related field such as an engineering discipline (e.g., electrical engineering, biomedical, mechanical, and/or computer science) and 2+ years of relevant experience

Previous experience in supporting manufacturing of electronic or electromechanical products in medical device industry, highly preferred

Previous experience working with conventional inspection and measurement equipment, preferred

Knowledge of design verification and validation process and practices, preferred

Knowledge of engineering design, test, and safety standards (IEC 60601-1 4TH Edition, FDA, ISO), preferred