Engineers (All Levels) (Medtech)

TL;DR

Engineers (All Levels) (Medtech): Developing and optimizing manufacturing processes for medical devices with an accent on NPI, process validation, and production efficiency. Focus on translating product designs into scalable manufacturing flows and driving continuous improvement to stabilize yield and quality.

Location: Onsite in Humacao, Puerto Rico, United States

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Design manufacturing processes, production layouts, and sequences of operations for assemblies and equipment installation.
• Develop process flows, work instructions, PFMEAs, and equipment requirements for New Product Introduction (NPI).
• Troubleshoot production floor issues, addressing nonconformances and equipment failures to ensure operational continuity.
• Lead process and equipment validations (IQ/OQ/PQ) and manage manufacturing readiness for design changes and production ramp-up.
• Ensure all processes and procedures are in strict compliance with FDA QSR, ISO 13485, and GMP regulations.

Requirements

• Engineering degree required.
• Experience requirements vary by level: Level I (0 years), Level II (2+ years), Senior (4+ years), or Principal (7+ years).
• Must possess unrestricted U.S. work authorization (Sponsorship is offered exclusively for Principal-level roles and above).
• Location: Must be based in or be able to work onsite in Humacao, Puerto Rico.

Nice to have

• Knowledge of CNC Programming, GD&T, and stack-up analysis.
• Proficiency in CAD software such as Creo, AutoCAD, or PartMaker.
• Certification in Lean Manufacturing or Six Sigma (Green Belt or Black Belt).
• Experience with sterile packaging and sterilization processes (ETO, Gamma).
• Proficiency in data analytics tools like Minitab, JMP, Power BI, or Python.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• Opportunity to work in a purpose-driven environment focused on global healthcare equity.
• Career growth opportunities within a massive global engineering organization.