Gandiv Insights LLC · 8 hours ago
New Product Introduction Engineer
Chicago, IL
Contract
Onsite
Mid, Senior Level
4+ years expGandiv Insights LLC is a company in the Medical Devices industry, seeking an NPI Engineer to facilitate the transition of new medical device products from R&D to full-scale manufacturing. The role involves ensuring production readiness and compliance with FDA and ISO regulations while leading various engineering activities.
Information Technology & Services
Responsibilities
Lead NPI and design transfer activities for Class II/III medical devices
Collaborate with R&D to define manufacturing requirements , BOM structure, and design-for-manufacturing (DFM) considerations
Develop and implement manufacturing processes, work instructions, and process flows
Support IQ/OQ/PQ validation , fixture qualification, and equipment readiness
Coordinate with suppliers for tooling, components, and manufacturing feasibility
Identify process gaps , risks, and improvements prior to production ramp-up
Support pilot builds , engineering builds (EVT/DVT/PVT), and clinical builds
Drive PFMEA, control plans, and process documentation
Work cross-functionally with Manufacturing, QA/RA, Supply Chain, and Operations
Resolve build issues related to design, materials, tolerance stack-ups, and assembly
Ensure compliance with ISO 13485, FDA 21 CFR 820, GMP , and internal QMS standards
Qualification
Required
Bachelor's degree in Mechanical, Manufacturing, Biomedical, or Industrial Engineering
4–8 years NPI or manufacturing engineering experience in medical devices
Hands-on experience with design transfer, pilot builds, V&V, and DFM
Knowledge of CAD tools (SolidWorks/Creo) and manufacturing documentation
Experience supporting IQ/OQ/PQ validation and fixture development
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