Gandiv Insights LLC ยท 6 days ago
Manufacturing Engineer - Medical Device
United States
Contract
Remote
Mid Level
4+ years expGandiv Insights LLC is a company focused on the medical devices industry, and they are seeking a Manufacturing Engineer to support production activities and process optimization. This role involves ensuring compliant production processes aligned with FDA and ISO standards while collaborating with various teams to drive continuous improvement and support new product introduction.
Information Technology & Services
Responsibilities
Support daily manufacturing operations , equipment, and process troubleshooting
Develop and update work instructions, BOMs, routers, and manufacturing documentation
Lead process validation activities (IQ/OQ/PQ) and equipment qualification
Drive continuous improvement , scrap reduction, and yield optimization initiatives
Support NPI and design transfer from R&D to manufacturing
Collaborate with Production, R&D, QA/RA, and Supply Chain teams
Specify and validate fixtures, jigs, and production tooling
Support line balancing, workflow optimization , and production layout improvements
Implement Lean, Six Sigma, and root cause analysis methodologies
Ensure compliance with FDA 21 CFR 820, ISO 13485 , and internal standards
Qualification
Required
Bachelor's in Mechanical, Manufacturing, Industrial, or Biomedical Engineering
4+ years of experience in medical device manufacturing engineering
Experience with process validation (IQ/OQ/PQ) and manufacturing support
Strong documentation skills in GMP / regulated environments
Proficiency with SolidWorks/Creo, fixtures, and tooling design
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