Principal Manufacturing Engineer (Medtech)

TL;DR

Principal Manufacturing Engineer (Medtech): Leading manufacturing process development and optimization for healthcare technology production with an accent on process design, equipment implementation, and validation. Focus on improving productivity, reducing costs, and ensuring regulatory compliance in high-quality medical device manufacturing.

Location: Humacao, Puerto Rico, USA

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

• Design manufacturing processes, procedures, and production layouts for assemblies and equipment installation.
• Optimize plant layouts to ensure the most efficient and productive arrangement of machinery.
• Develop fabrication procedures for tools and equipment to enhance product performance.
• Inspect and verify the efficiency of machinery and tools, initiating corrective actions for deficiencies.
• Implement statistical process control (SPC) and develop applicable manufacturing processes.
• Ensure all production processes and procedures comply with industry regulations.

Requirements

• Bachelor's degree in Engineering is required.
• Experience: Minimum 7 years (Baccalaureate), 5 years (Master's), or 3 years (PhD).
• Must have valid U.S. work authorization (Sponsorship is offered exclusively for Principal-level roles).

Nice to have

• Proficiency in CNC Programming, GD&T, and CAD software (Creo, AutoCAD).
• Experience with Process Validation (DOE, IQ, OQ, PQ) and Gage R&R.
• Knowledge of Automation, Robotics, and PLC programming.
• Certification in Lean Manufacturing & Six Sigma (Green/Black Belt).
• Familiarity with FDA QSR, ISO 13485, and GMP regulations.
• Skills in data analytics tools such as Minitab, JMP, Power BI, or Python.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligible for the hirify.global Incentive Plan (MIP) short-term incentive.
• Purpose-driven work environment focused on improving patient lives globally.
• Commitment to equal employment opportunity and an inclusive workplace.