Validation Engineer

The Validation Engineer will have primary responsibilities in planning, designing, developing, implementing, and monitoring the validation strategies that support the release of next generation medical devices. In this role, you will function as a cross functional team member developing test protocols based on requirements, documentation, and feedback to impact patient outcomes. This position is based onsite at our Guilford, CT headquarters with hybrid flexibility.

Core 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).

Qualifications / Requirements:

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

Preferred candidates will have a 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.

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.

Work Environment and Physical Demands:

Work environment is primary based in an office and frequently within an engineering lab setting. Hybrid remote capable.

Physical demands are primarily light work which includes sitting as well as frequent walking/standing throughout location(s)and lifting up to 20lbs to carry lightweight test equipment, fixtures, and devices

Compensation and Benefits:

Defibtech offers competitive salaries and a comprehensive benefits package including core health benefits, company-paid disability, and a company matching 401k plan.

Defibtech promotes a challenging, collaborative, and friendly culture that is centered around our values: Passion, Innovation, Integrity, and Ownership.

Defibtech is supportive of work balance, providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.

Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.

Defibtech is committed to a diverse workplace and is an Equal Opportunity/Affirmative Action employer and E-Verify Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

The above description of core responsibilities and qualifications are intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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