Manufacturing Engineer – Medical Devices | Onsite PR

EQVAL Group, Inc; Juncos (PR); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Life Insurance

Paid time off (PTO)

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer to drive validation (IQ/OQ/PQ) and optimize manufacturing processes for Medical Device and Pharmaceutical environments.

This on-site role in Juncos requires strong cGMP knowledge and hands-on validation experience. Responsibilities include leading validation activities, designing efficient production layouts, and collaborating on investigations (NCRs/ CAPA) to improve quality and throughput.

Qualifications

• Bachelor’s degree in Engineering with Medical Device or Pharmaceutical exposure.
• Experience developing Validation Plans, URS, FRS, IQ, OQ, PQ and related reports.
• Hands-on FDA inspections, ISO audits, change control, non-conformance, CAPA.
• Strong cGMP knowledge for Medical Device manufacturing environments.
• Proficient in data analysis and GR&R; familiarity with Minitab.
• Bilingual English and Spanish communication skills.

Responsibilities

• Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
• Design and optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication.
• Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality.
• Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions.
• Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities.

Skills

Validation expertise

Process optimization

Troubleshooting

Statistical analysis (GR&R, MSA)

Lean Six Sigma

DOE (Design of Experiments)

Problem solving

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering

Tools

Minitab

CAPA documentation

pFMEA

Job description

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer to drive validation (IQ/OQ/PQ) and optimize manufacturing processes for Medical Device and Pharmaceutical environments.

This on-site role in Juncos requires strong cGMP knowledge and hands-on validation experience. Responsibilities include leading validation activities, designing efficient production layouts, and collaborating on investigations (NCRs/ CAPA) to improve quality and throughput.