Senior Project Manager (Medical Devices)

Location: Alajuela, Costa Rica

Company

hirify.global develops and manufactures medical device products and related components within the Freudenberg Group.

What you will do

• Build and lead internal teams, suppliers, vendors, and contractors to deliver projects within scope, schedule, cost, and quality targets.
• Act as the primary contact for customers, clinicians, Sales, Finance, Operations, and other stakeholders; manage expectations and negotiate changes.
• Manage budgets, internal billing, cost-of-goods development, quoting, pricing support, and make-or-buy decisions.
• Oversee multiple complex or high-risk projects, resource allocation, project documentation, metrics, reporting, and audit readiness.
• Lead design history files, device master records, risk analyses, validation protocols and reports, change control, and traceability.
• Mentor project members and drive continuous improvement through Lean/Six Sigma and GROWTTH methodologies.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related science or technical field.
• At least 5 years of experience in the medical device or related industry and 4 years of project management experience in manufacturing.
• Experience managing project schedules, budgets, scope, progress, reporting, and multiple high-complexity projects.
• Experience with silicone, plastics, and/or extrusion, plus medical device processes such as injection molding, catheter manufacturing, equipment operation, and assembly.
• Strong knowledge of ISO 13485, ISO 14001, ISO 14971, GMP, and country-specific medical device regulations including 21 CFR 820.
• Experience with formal problem-solving methods, critical thinking, Lean/Six Sigma tools, team leadership, and employee mentoring.

Culture & Benefits

• Work in a culture focused on efficiency, innovation, quality, delivery, cost improvement, and regulatory excellence.
• Support diversity, inclusion, and equal employment opportunity.
• Contribute to projects requiring audit-ready documentation and compliance with notified-body expectations.