Verification & Validation (V&V) Engineer

Job Title: Verification & Validation (V&V) Engineer
Location: Marlborough, MA, USA (100% onsite)
Schedule: Mon-Fri, 8 AM - 5 PM
Pay Rate: $114/Hour

We are seeking a skilled Verification & Validation (V&V) Engineer with a strong background in the development and manufacturing of plastic disposable kits for regulated industries. In this role, you will be responsible for driving the V&V processes to ensure product quality and compliance with industry standards.

• Derive test requirements from specifications, define test plans and methodologies, and estimate resources for design verification and validation campaigns.
• Establish acceptance criteria, assess through modeling or qualitative/quantitative testing, and evaluate performance according to User Requirement Specifications (URS) and System Requirement Specifications (SRS).
• Write test protocols, set up design of experiments, execute tests, analyze results, and document reports for V&V activities with a focus on quality and compliance.
• Perform Test Method Validation and Equipment Qualification.
• Lead root cause analysis and investigations on test failures during V&V activities.
• Develop guidelines for performing disposables kit V&V activities and standardize practices within the Disposables & Materials Engineering Team.

• 7 years of experience in Verification and Validation processes, specifically in developing and manufacturing plastic disposable kit products for regulated industries (preferably medical devices, Class II and/or Class III).
• Master’s degree or equivalent experience in related engineering or scientific fields (mechanics, micro-mechanics, materials).
• Strong knowledge and practical experience of relevant regulations (ISO 13485, FDA 21 CFR Part 820) for US and European market product submissions.
• Demonstrated experience in defining and managing V&V plans, test execution, risk mitigation, statistical data analysis, and reporting.
• Experience with V&V activities related to disposable kits for medical devices, including manufacturing processes like injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, and solvent bonding.
• Hands-on experience in test method validation (e.g., DOE, OQ, Gage R&R), mechanical testing (e.g., pull/peel test, burst test, leak test, dye test, bubble test), packaging design, transportation conditions simulation (e.g., ISTA), and stability studies (e.g., pre-conditioning, aging tests).
• Strong organizational and communication skills in a multidisciplinary, multicultural matrix organization. Fluent in written and spoken English. Self-starter with creative problem-solving skills to address conflicting requirements and technical risks.