Process Development Engineer

Weil Group, Inc; Dorado (PR); On-site; USD 110,000 - 150,000; Full time

Job summary

Weil Group, Inc. is seeking a Process Development Engineer to support the development, validation, and implementation of new manufacturing processes in a FDA-regulated setting.

The role involves equipment validation, documentation generation, process optimization, and cross-functional collaboration with engineering and quality teams. Candidates typically have 5–7+ years in manufacturing or quality engineering and a BS in Engineering.

Qualifications

• BS in Engineering, 3.00 GPA minimum.
• 5–7+ years in FDA-regulated manufacturing or quality engineering.
• Experience with DOE, FMEA, CAPA and root-cause investigation.
• Strong knowledge of GMP, ISO 13485 and 21 CFR Part 820.

Responsibilities

• Support IQ/OQ/PQ and development of validation protocols, reports, and master validation plans.
• Design and develop in-process and receiving inspection systems for new components and processes.
• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
• Manage process development projects from concept through implementation.
• Apply DOE, PFMEA, and risk analysis to optimize processes.
• Work with laser welding, heat bonding, injection molding, vision systems, and automation technologies.

Skills

DOE

FMEA

CAPA

Root Cause

Automation

Validation

21 CFR 820

ISO 13485

Education

BS in Engineering

Tools

Laser Welding

Vision Systems

PLC/Servo

Pneumatics

Job description

Role Summary

The Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process validation, documentation generation, process optimization, and cross-functional technical collaboration.

Key Responsibilities

• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
• Design and develop in-process and receiving inspection systems for new components and processes.
• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
• Manage process development projects from concept through implementation; collaborate with cross-functional teams.
• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).

Experience Requirements

• 5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).
• Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.
• Electrical and mechanical engineering background applied to automated manufacturing systems.
• Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.
• Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.
• Experience supporting new product introductions and process scale‑up.

Quality Expectations

Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
Ensures proper documentation discipline and supports Quality System compliance.
Special requirement:

• 3.00 GPA minimum
• RUM or Polytechnic University graduates
• BS in Engineering

Weil Group is proud to be an Equal Employment Opportunity Employer.