Process Engineer (2 years+) (Medical Manufacturing)

Location: Humacao, Puerto Rico, United States of America; onsite

Company

hirify.global develops healthcare technologies designed to alleviate pain, restore health, and extend life.

What you will do

• Provide technical and sustaining engineering support in a manufacturing area.
• Recommend and implement equipment and process modifications to improve quality, efficiency, manufacturing techniques, and production yields.
• Develop, optimize, characterize, and validate manufacturing processes, including equipment, materials, tooling, fixtures, and measurement systems.
• Lead feasibility studies, process and equipment selection, installation, assessment, and technology transfer to manufacturing operations.
• Collaborate with R&D, product design, Quality, Operations, Supply Chain, and suppliers to align processes with product requirements.
• Ensure processes comply with applicable regulations while supporting statistical analysis, cost reduction, and value engineering.

Requirements

• Bachelor’s degree in engineering and at least 2 years of relevant experience, or a master’s degree with 0 years of relevant experience.
• Lean Manufacturing and Six Sigma experience with Green Belt or Black Belt certification.
• Advanced statistical analysis skills, including DOE, SPC, MSA, and process capability studies.
• Experience with automation, digital manufacturing, equipment qualification and validation, including IQ/OQ/PQ.
• Knowledge of FMEA, Fault Tree Analysis, FDA QSR, ISO 13485, and GMP.
• Must have unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Nice to have

• Experience with Minitab, JMP, Power BI, or Python for data analysis.
• Supplier process development and oversight experience.
• Experience with change management, ECO execution, NCMR and CAPA investigations, and technology transfer.
• Project management knowledge, including Agile or PMP fundamentals.
• Experience mentoring or technically coaching junior engineers.

Culture & Benefits

• Full-time employment at a global healthcare technology company.
• Competitive compensation and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan short-term incentive.
• Reasonable accommodations are available for qualified individuals with disabilities.