Process Development Engineer: Medical Devices & Pharma (On-Site PR)

EQVAL Group, Inc; Dorado (PR); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Life Insurance

Paid time off

Holidays

Professional Growth (Courses and CERTs

EQVAL Academy

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. seeks a Process Development Engineer to support development, validation, and implementation of new manufacturing processes. Responsibilities include DOE/PFMEA/risk analysis and cross-functional collaboration, with focus on automation and advanced manufacturing equipment.

The role requires a Bachelor's in Engineering (Electrical/Mechanical) and is fully on-site in Puerto Rico, with bilingual English/Spanish proficiency and experience in regulated environments.

Qualifications

• Bachelor Degree in Engineering (Electrical and Mechanical backgrounds preferred).
• Previous experience in regulated industry (Pharma, Biotech, or Medical Devices).
• Experience with automated manufacturing system and equipment (laser welding, heat bonding, injection molding, vision systems).
• Experience with automation/controls, tooling, fixtures, test method development.
• Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.
• Good technical writing skills.
• Fully bilingual (English and Spanish).

Responsibilities

• Perform process validation and equipment qualification activities / reports (IQ, OQ, PQ) and develop Master Validation Plans.
• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
• Design and develop in-process and receiving inspection systems for new components and processes.
• Characterize, optimize, and improve manufacturing processes through DOE, PFMEA, and risk analysis.
• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).

Skills

DOE

FMEA

CAPA

Root-cause analysis

Technical writing

Bilingual English/Spanish

Education

Bachelor's degree in Engineering (Electrical or Mechanical preferred)

Tools

Laser welding

Heat bonding

Injection molding

Vision systems

PLC/Servo/Pneumatics

Job description

EQVAL Group, Inc. seeks a Process Development Engineer to support development, validation, and implementation of new manufacturing processes. Responsibilities include DOE/PFMEA/risk analysis and cross-functional collaboration, with focus on automation and advanced manufacturing equipment.

The role requires a Bachelor's in Engineering (Electrical/Mechanical) and is fully on-site in Puerto Rico, with bilingual English/Spanish proficiency and experience in regulated environments.