Director, Manufacturing Engineering (Medical Devices)

Location: Heredia, Costa Rica; on-site with a minimum of four days per week in the office. Travel up to 25%, including international travel to suppliers and manufacturing sites.

Company

hirify.global develops the Omnipod wearable, waterproof medical-device product platform to help customers live simpler and healthier lives.

What you will do

• Lead the global Manufacturing Engineering function and build the multidisciplinary engineering organization for the Costa Rica greenfield manufacturing site.
• Plan and execute equipment design, procurement, factory and site acceptance testing, installation, commissioning, qualification, process validation, and production-line start-up.
• Lead engineering support for equipment reliability, maintenance, facilities, automation, NPI, process engineering, test engineering, industrial engineering, and validation.
• Drive manufacturing performance through safety, quality, uptime, yield, line efficiency, preventive maintenance, calibration, cost, and project-execution metrics.
• Coordinate Operations, Quality, Regulatory, Supply Chain, Finance, IT, Global Engineering, and external suppliers to resolve technical risks and deliver production readiness.
• Manage CAPEX and OPEX, resource allocation, technical capability development, succession planning, continuous improvement, and operational excellence.

Requirements

• Bachelor’s degree in Manufacturing, Mechanical, Electrical, Industrial, or a related Engineering discipline.
• 10+ years of progressive experience in high-volume manufacturing, engineering, plant engineering, maintenance, automation, or related operations, including 7+ years leading engineering teams.
• Experience building and leading multidisciplinary technical teams and supporting greenfield manufacturing start-up, production ramp, or capacity expansion.
• Experience with automated discrete-component assembly, equipment lifecycle management, production-line start-up, manufacturing scale-up, and process capability.
• Working knowledge of FAT, SAT, TMV, IQ, OQ, PQ, equipment qualification, process validation, SPC, root-cause analysis, Lean, and Six Sigma.
• Experience in regulated manufacturing and quality-system environments; medical-device, FDA-regulated, and ISO 13485 experience is strongly preferred.

Nice to have

• Master’s degree or MBA.
• Experience with CMMS, MES, ERP integration, enterprise asset management, and manufacturing equipment data systems.
• Prior plant or manufacturing-line start-up experience and experience supporting technology transfers, obsolescence programs, or next-generation product development.

Culture & Benefits

• Work in a cross-functional environment spanning Manufacturing Engineering, Operations, Quality, Regulatory, Supply Chain, Finance, IT, and Global Engineering.
• Support global manufacturing operations, including current plants, the planned Acton, Massachusetts manufacturing site, and future expansion locations.
• Work in a Class 8 cleanroom environment as needed and adjust the schedule for shift coverage when required.
• Lead a culture focused on accountability, inclusion, continuous improvement, disciplined execution, and operational excellence.