Validation Engineer at Nihon Kohden America in Guilford, CT

Job description

• Defibtech is seeking a Validation Engineer to join our Research & Development team! This position will be based onsite at our Guilford, Connecticut site, with hybrid flexibility.
• 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.

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 and 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 Management Systems Regulations, safety regulations, and applicable statutes).

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.

Skills

Required

• Statistical methods
• Test method development
• Validation protocols
• Design verification and validation
• Test automation
• Test equipment and fixture design
• Testing software
• IEC 60601-1 4TH Edition
• FDA regulations
• ISO standards

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. and mission.
• 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.