Director, Manufacturing Engineering
Core
Senior technical leader for the Costa Rica manufacturing site responsible for building and leading a multidisciplinary engineering organization to support plant start-up, greenfield operations, and ongoing production of medical devices.
Role type
Director, Manufacturing Engineering (Senior IC with leadership)
Builds
Medical device manufacturing plants, production lines, and engineering teams
Domain
Medical device manufacturing, high-volume discrete-component assembly, FDA-regulated environments
Required skills
Manufacturing engineering, equipment lifecycle management, process validation (IQ/OQ/PQ), Lean Six Sigma, SPC, team leadership, CAPEX/OPEX management, regulatory compliance (ISO 13485/FDA), automation, facility engineering (via careerplan.io/jobs/REQ-2026-18566-director-manufacturing-engineering-at-insulet)
Preferred skills
Greenfield manufacturing launch, medical-device experience, FDA-regulated environment experience, CMMS/MES/ERP integration, MBA
Technologies
CMMS, MES, ERP, automated assembly equipment
Responsibilities
Establish strategic priorities and governance for the manufacturing engineering organization; lead multidisciplinary teams in equipment design, installation, commissioning, and validation; manage departmental budgets and financial performance; drive continuous improvement methodologies; ensure compliance with quality and safety regulations; support global manufacturing start-up activities.
Seniority
Director, strategic leadership and hands-on technical execution