Director, Manufacturing Engineering

About the role

The Director, Manufacturing Engineering leads the multidisciplinary engineering organization for Insulet’s Costa Rica manufacturing site, overseeing equipment, process, maintenance, automation, validation and continuous improvement activities for both greenfield start‑up and ongoing production.

Key responsibilities

• Provide strategic and technical leadership for the site’s Manufacturing Engineering function, establishing priorities, governance and performance metrics.
• Build, coach and develop teams covering equipment design, NPI, process engineering, test, facilities, industrial engineering, automation and validation.
• Lead equipment design reviews, procurement, FAT/SAT, installation, commissioning, qualification and production‑line start‑up.
• Own engineering KPIs for safety, quality, cost, equipment uptime, process yield, line efficiency and preventive maintenance.
• Establish preventive‑maintenance, calibration, spare‑parts and reliability strategies for equipment and facilities.
• Drive data‑based problem solving using SPC, Lean, Six Sigma and mistake‑proofing methodologies.
• Ensure compliance with FDA, ISO 13485, environmental, health and safety requirements.
• Manage departmental CAPEX/OPEX, project budgets, resource allocation and financial performance.

Required profile

• Bachelor’s degree in Manufacturing, Mechanical, Electrical, Industrial or related engineering; Master’s or MBA preferred.
• 10+ years in high‑volume manufacturing or plant engineering, preferably medical‑device.
• 7+ years of engineering leadership experience building multidisciplinary technical teams.
• Proven experience launching or expanding a greenfield manufacturing operation.
• Strong financial acumen, analytical problem‑solving and cross‑functional influence.

Required skills

• Equipment design and lifecycle management
• FAT, SAT, TMV, IQ, OQ, PQ validation methodologies
• FDA‑regulated and ISO 13485 quality‑system environments
• CMMS, MES, ERP integration
• Lean manufacturing, Six Sigma, SPC, process‑capability analysis
• Automation and industrial control systems
• Preventive maintenance and asset‑management strategies