MedTech Validation Engineer — Hybrid & Impactful

Nihon Kohden North America, Inc.; Guilford (CT); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Health benefits

Disability insurance

401k plan

Job summary

Defibtech seeks a Validation Engineer to join our R&D team in Guilford, CT, with onsite work and hybrid flexibility. You will plan, design, develop, implement, and monitor validation strategies to support the release of next generation medical devices, collaborating cross-functionally to impact patient outcomes.

You will develop and execute validation protocols, analyze results for FDA/CE reporting, and ensure documentation meets regulatory requirements while supporting multiple projects.

Qualifications

• 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 and 2+ years of relevant experience.
• Previous experience in supporting manufacturing of electronic or electromechanical products in medical device industry is highly preferred.
• Previous experience working with conventional inspection and measurement equipment is preferred.
• Knowledge of design verification and validation process and practices is preferred.
• Knowledge of engineering design, test, and safety standards (IEC 60601-1 4TH Edition, FDA, ISO) is preferred.
• Strong analytical and problem-solving ability.
• Strong technical writing ability for design validations and reports.
• Strong written and oral communication skills.
• 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.

Responsibilities

• Supports the development of validation plans for medical device design functions (software, electrical and mechanical).
• 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.
• Documents activities in accordance with best engineering practices and regulatory requirements.
• Participates in Design Reviews and provides verification support to development teams (Code Reviews, Software Module and System testing, test automation, testing procedures).
• Designs test equipment, test fixtures, and testing software for diagnosis of medical devices.
• Supports compliance with FDA, Quality Management Systems Regulations, safety regulations, and applicable statutes.

Education

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

Tools

Testing software

Test fixtures

Job description

Defibtech seeks a Validation Engineer to join our R&D team in Guilford, CT, with onsite work and hybrid flexibility. You will plan, design, develop, implement, and monitor validation strategies to support the release of next generation medical devices, collaborating cross-functionally to impact patient outcomes.

You will develop and execute validation protocols, analyze results for FDA/CE reporting, and ensure documentation meets regulatory requirements while supporting multiple projects.