Process Engineers (Medical Devices)

Location: Humacao, Puerto Rico, United States of America; onsite manufacturing engineering role. Candidates below the Principal level must have unrestricted U.S. work authorization at hire and throughout employment.

Company

hirify.global develops medical technologies intended to alleviate pain, restore health, and extend life.

What you will do

• Develop, optimize, and sustain manufacturing processes to improve quality, efficiency, throughput, yield, and process capability.
• Lead continuous improvement using Lean Manufacturing, Six Sigma, statistical methods, and data-driven analysis.
• Evaluate and implement equipment, tooling, automation, and process enhancements.
• Lead equipment qualification and process validation activities, including IQ, OQ, and PQ.
• Partner with R&D and Product Development on manufacturability, technology transfer, scale-up, and new product introductions.
• Support risk assessments, nonconformance investigations, CAPA, engineering changes, and regulatory documentation.

Requirements

• Senior level: Bachelor’s degree in Engineering and 4+ years of manufacturing engineering experience, or a Master’s degree and 2+ years, or a PhD in Engineering.
• Principal level: Bachelor’s degree in Engineering and 7+ years of experience, or a Master’s degree and 5+ years, or a PhD in Engineering and 3+ years.
• Experience with Lean Manufacturing, Six Sigma, DOE, SPC, MSA, process capability analysis, equipment qualification, and process validation.
• Knowledge of FDA Quality System Regulations, ISO 13485, GMP, and quality system requirements.
• Experience with nonconformance investigations, CAPA activities, and engineering change implementation.
• Roles below Principal require unrestricted U.S. work authorization. U.S. work authorization sponsorship is offered only for Principal-level roles and above.

Nice to have

• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with automation, digital manufacturing, Industry 4.0, or smart factory technologies.
• Experience with Minitab, JMP, Power BI, Python, DFM, DFA, supplier process development, or project management.
• Experience mentoring junior engineers and leading cross-functional technical initiatives.

Culture & Benefits

• Mission-driven work focused on healthcare technology and patient outcomes.
• Competitive compensation and flexible benefits package.
• Short-term incentive eligibility through the hirify.global Incentive Plan.
• Reasonable workplace accommodations are available for qualified individuals with disabilities.