[Defibtech is seeking a [Validation Engineer responsible for [planning, designing, developing, implementing, and monitoring the validation strategies that support the release of next generation medical devices. This role will work in a cross functional team developing test protocols based on requirements, documentation, and feedback to impact patient outcomes.[ This position is hybrid remote capable based at our headquarters in Guilford, CT.

[Core Responsibilities: ]{arial",sans-serif"=""}]{arial",sans-serif"=""}]{arial",sans-serif"=""}]{arial",sans-serif"=""}]{arial",sans-serif"=""}

• Supports the development of validation plans for medical device design functions (software, electrical and mechanical), define 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 Defibtechs 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).

[Qualifications / Requirements: ]{arial",sans-serif"=""}

Bachelors degree and 0-2 years of related experience or the equivalent combination of education, experience, and training.

Preferred candidates will have a bachelors 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.

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.