Overview
Verification and Validation Engineer —Marlborough, MA, Hybrid Jobs in Middlesex County, MA at Largeton Group
Title: Verification and Validation Engineer —Marlborough, MA, Hybrid
Company: Largeton Group
Location: Middlesex County, MA
Job Responsibilities:
Lead and execute Verification and Validation (V&V) activities for disposable kit development.
Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.
Set-up design of experiments (DOE) and/or review plan and results to support product evaluation and process development.
Establish acceptance criteria and sampling plans.
Develop best practice guidelines for performing disposables kit Verification & Validation activities.
Perform and document technical root cause investigations.
Support Risk Analysis activities within the R&D team.
Advise R&D team members on execution of process validation (IQ/OQ/PQ) activities.
Support R&D supplier capability and quality audits.
Mitigate project technical risks, resolve issues, deliver on-time.
Assess product specifications and change control documentation for improving the manufacturing of new and existing devices.
Support R&D team in developing supplier quality plans, supplier specifications and defining CTQ requirements.
Required Skills:
Bachelor’s degree or equivalent in related engineering or scientific fields.
6-10+ years of experience in designing, developing, and manufacturing plastic disposable kit products.
Experience in verification activities related to disposable kits for medical device application.
Expertise in test method validation (e.g. DOE, OQ, Gage R&R), mechanical testing.
Familiarity with disposable product manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, and ISO class 7 & 8 cleanroom operations.
Desirable Skills:
Knowledge of materials biocompatibility (ISO 10993 and USP 88), leachable & extractable (E&L) evaluations, and sterilization techniques.
Experience with medical device risk management and risk analysis (ISO 14971).
Knowledge of statistical data analysis, methods, and tools (Minitab or equivalent).
Experience with test method validation (TMV), Gage R&R, and process capability analysis.
Education Qualification: Bachelor’s degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials).
Thanks & Regards
Sahit Kashyap
Sr. Technical Recruiter
Phone:
571-416-8784
EXT :
377
Email:
LARGETON INC.
13800 Coppermine Rd, Herndon, VA 20171
Disclaimer
Largeton is an equalopportunity employer. There
is no discrimination based on race, colour,religion, sex, national origin, age,
disability, or any other protected status.
If you believe you have been treated unfairly, please contact our HR department
