Sr Engineer - Process & Product (Medical Devices)

Location: Aibonito, Puerto Rico

Company

hirify.global develops healthcare products and supports medical device manufacturing operations focused on saving and sustaining lives.

What you will do

• Provide engineering support for manufacturing processes, product development, and process improvements.
• Lead and support new product introductions, product transfers, process changes, and product lifecycle activities.
• Maintain and execute process and product validation and revalidation programs.
• Analyze and resolve process issues using statistical analysis, PFMEA, 5 Whys, DOE, SPC, and Six Sigma tools.
• Own change controls and project actions, manage technical resources, and lead or support small cross-functional project teams.
• Support internal and external audits, serve as a technical approver, and ensure EHS, confidentiality, and data privacy compliance.

Requirements

• Bachelor’s degree in Mechanical, Industrial, Electrical, or Chemical Engineering.
• 3–5 years of experience in manufacturing engineering or a related field.
• Strong knowledge of validation processes, product lifecycle management, quality systems, and regulatory requirements including FDA and MDSAP.
• Experience with statistical analysis and continuous improvement tools; Six Sigma is preferred.
• Ability to manage multiple projects and work independently with minimal supervision, supported by strong problem-solving, communication, and leadership skills.
• Bilingual Spanish and English, orally and in writing, is required.

Culture & Benefits

• Cross-functional collaboration with quality, production, and divisional engineering teams.
• Medical, dental, disability, life, and vision coverage.
• Paid vacation, holidays, and parental leave.
• Retirement plan, employee stock purchase program, and educational assistance.
• Focus on a zero-harm workplace and compliance with EHS policies.