Validation Engineer

Nihon Kohden America; United States; Hybrid; USD 70,000 - 95,000; Full time

Job summary

Defibtech is seeking a Validation Engineer to join the R&D team in Guilford, Connecticut. This onsite role offers hybrid flexibility, supporting the validation strategies for next-generation medical devices as part of a cross-functional team.

You will develop protocols from requirements, execute validation activities, and ensure proper documentation to aid FDA and CE Mark approvals while contributing to continuous improvement in quality systems.

Qualifications

• Bachelors degree and 0-2 years of related experience or equivalent
• Preferred: engineering discipline (electrical/biomedical/mechanical/computer science) with 2 years relevant experience
• Experience supporting manufacturing of electronic or electromechanical medical devices
• Knowledge of design verification and validation processes and practices

Responsibilities

• Plan, design, develop, implement and monitor validation strategies for medical devices.
• Develop and execute validation protocols based on system requirements and standards (ISO/FDACollates, FDA, CE).
• Document activities per best engineering practices and regulatory requirements.
• Participate in Design Reviews and provide verification support to development teams.
• Design test equipment, fixtures and software for device diagnosis and testing.

Skills

Analytical thinking

Technical writing

Team collaboration

Education

Bachelor's degree in engineering or related field

Tools

Test equipment

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 sizesDevelops and executes validation protocols based on system requirements and approved procedures and standards ISO and FDACollates analyzes summarizes and interprets validation protocol results into cohesive reporting for FDA and CE Mark approvalsProperly documents activities in accordance with best engineering practices company procedures and regulatory requirementsParticipates in Design Reviews and provides verification support to development teams eg Code Reviews Software Module and System testing test automation testing proceduresDesigns test equipment test fixtures and testing software for diagnosis of medical devicesDemonstrates Defibtechs values on the job and promotes and participates in continuous improvementActively 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

Bachelors degree and 0 2 years of related experience or the equivalent combination of education experience and trainingPreferred candidates will have a bachelors degree in a science related field such as an engineering discipline eg electrical engineering biomedical mechanical andor computer science and 2 years of relevant experiencePrevious experience in supporting manufacturing of electronic or electromechanical products in medical device industry highly preferredPrevious experience working with conventional inspection and measurement equipment preferredKnowledge of design verification and validation process and practices preferredKnowledge of engineering design test and safety standards IEC 60601 1 4TH Edition FDA ISO preferredStrong analytical and problem solving abilityStrong technical writing ability for design validations and reportsStrong written and oral communication skills to accurately convey issues and informationStrong organizational skills and attention to detailAbility to support multiple projects concurrently while maintaining quality and meeting deadlinesAbility 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 capablePhysical demands are primarily light work which includes sitting as well as frequent walkingstanding throughout locations 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 planDefibtech promotes a challenging collaborative and friendly culture that is centered around our values and missionDefibtech is supportive of work balance providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilitiesDefibtech 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 2034536654 This contact information is for accommodation requests only and should not be used to inquire about the status of applications