Process Engineer (Medtech)

TL;DR

Process Engineer (Medtech): Leading process development, optimization, and validation in a regulated manufacturing environment with an accent on continuous improvement and compliance. Focus on driving scalable, cost-effective manufacturing solutions, conducting root cause analysis, and ensuring adherence to FDA and ISO quality standards.

Location: Must be based in Humacao, Puerto Rico, United States

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life for millions of patients worldwide.

What you will do

• Provide technical and sustaining engineering support within a manufacturing area.
• Recommend and implement equipment and process modifications to improve production efficiencies and yields.
• Lead the innovation, development, and optimization of manufacturing concepts for transfer to operations.
• Ensure all processes and procedures remain in strict compliance with regulatory standards.
• Collaborate cross-functionally with R&D, Quality, and Supply Chain teams to ensure design compatibility.
• Conduct statistical analysis and develop measurement systems for process control.

Requirements

• Bachelor's degree in engineering required.
• Minimum of 2 years of relevant experience (or higher based on seniority level).
• Lean Manufacturing & Six Sigma (Green Belt or Black Belt certification).
• Regulatory knowledge (FDA QSR, ISO 13485, GMP).
• Equipment qualification & validation leadership (IQ/OQ/PQ).
• Unrestricted U.S. work authorization required for roles below Principal level.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Participation in the hirify.global Incentive Plan (MIP).
• Commitment to purpose-driven work and professional growth.
• Inclusive environment with equal employment opportunity policies.