Gandiv Insights LLC · 5 hours ago
Process Validation Engineer - Medical Device
United States
Contract
Remote
Senior Level
5+ years expGandiv Insights LLC is seeking a Process Engineer to support medical device manufacturing operations by developing, optimizing, and validating manufacturing processes. This role involves collaboration with various teams to ensure efficient and compliant production processes in a GMP-regulated environment.
Information Technology & Services
Responsibilities
Develop, optimize, and maintain manufacturing processes for medical devices
Support process characterization and process validation (IQ/OQ/PQ) activities
Identify and implement process improvements to enhance yield, efficiency, and product quality
Support new product introductions (NPI) and technology transfer to manufacturing
Create and maintain process documentation, work instructions, and SOPs
Collaborate with R&D, Manufacturing, Validation, and Supply Chain teams
Troubleshoot manufacturing issues using root cause analysis and implement corrective actions
Ensure compliance with FDA 21 CFR 820, ISO 13485, and internal quality standards
Qualification
Required
Bachelor's degree in Mechanical, Manufacturing, Biomedical Engineering, or related field
4+ years of experience in medical device manufacturing or process engineering
Hands-on experience with process validation and equipment qualification
Strong understanding of GMP and medical device regulations
Excellent problem-solving and documentation skills
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase