Validation Engineer

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 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.

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 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).

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. 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.

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.

Defibtech endeavors to make our application process accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.