Gandiv Insights LLC · 18 hours ago
Manufacturing Engineer – Medical Device
Raleigh, NC
Contract
Onsite
Mid, Senior Level
3+ years expGandiv Insights LLC is seeking a Manufacturing Engineer to support development and validation of medical device manufacturing processes in a GMP environment. The role involves ensuring efficient, compliant production of Class I/II/III devices through process validation and equipment qualification.
Information Technology & Services
Responsibilities
Develop and optimize manufacturing processes for Class I/II/III medical devices
Execute IQ/OQ/PQ and support equipment qualification
Troubleshoot production issues and implement corrective actions (CAPA)
Support new product introduction (NPI) and technology transfer
Maintain manufacturing documentation (SOPs, work instructions, DHRs)
Ensure compliance with FDA 21 CFR Part 820 and ISO 13485
Drive process improvements using Lean/Six Sigma tools
Qualification
Required
3–7 years of experience in medical device manufacturing
Experience working in GMP-regulated environments
Strong understanding of FDA 21 CFR Part 820
Strong understanding of ISO 13485
Strong understanding of ISO 14971 (Risk Management)
Strong understanding of Process Validation (IQ/OQ/PQ)
Hands-on experience with equipment troubleshooting and production support
Preferred
Experience with sterile or non-sterile device manufacturing preferred
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