Validation Engineer - Hyper Recruitment Solutions

We are currently looking for a Validation Engineer to join a leading Medical Devices company based in the Marlborough, Massachusetts area. As the Validation Engineer, you will play a pivotal role in ensuring the quality and compliance of new part development, particularly in the regulated medical device industry.

This is an initial 9 month contract with possible extension.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Validation Engineer will be varied however the key duties and responsibilities are as follows:

1. As the Validation Engineer, you will derive test requirements from design specifications, define test plans and methodologies, and estimate resources for design verification and validation campaigns.
2. As the Validation Engineer, you will write test protocols, set up design experiments, execute tests, analyze results, and document reports with a focus on quality, compliance, and execution rigor.
3. As the Validation Engineer, you will perform Test Method Validation and Equipment Qualification (IQ/ OQ/ PQ).
4. As the Validation Engineer, you will lead root cause analysis and investigations on test failures through Verification & Validation activities.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as the Validation Engineer, we are looking to identify the following on your profile and past history:

1. Relevant degree in a related engineering or scientific field.
2. Extensive industry experience in Design Verification and Validation, particularly in developing and manufacturing plastic disposable kit products for regulated industries.
3. A working knowledge and practical experience in the Medical Devices industry (ISO13485, ISO11607, FDA 21 CFR Part 820) and statistical data analysis.

Key Words: Validation Engineer / Design Verification / Test Method Validation / Gage R&R / Statistical Data Analysis / Medical Device / ISO13485 / FDA 21 CFR Part 820 / Equipment Qualification / Root Cause Analysis / IQ / OQ / PQ / FAT / SAT / cGMP

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.