Process Development Engineer - Dorado, PR - On site

Integrated Services for Productivity & Validation, Inc; Dorado (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading provider of manufacturing solutions is seeking a Process Development Engineering contractor in Dorado, Puerto Rico. The successful candidate will support the development, validation, and implementation of manufacturing processes. Responsibilities include process qualification activities and collaboration with cross-functional teams. Applicants should have 5–7+ years of experience in an FDA-regulated environment and strong knowledge of relevant regulations. This position offers a chance to work with advanced technologies in a crucial industry.

Qualifications

• 5–7+ years in manufacturing engineering or quality engineering within an FDA-regulated environment.
• 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.

Responsibilities

• Support IQ/OQ/PQ and process performance qualification activities.
• Design and develop in-process and receiving inspection systems.
• Generate equipment documentation and manufacturing instructions.
• Manage process development projects from concept through implementation.
• Apply DOE, PFMEA, and risk analysis to optimize manufacturing processes.
• Work with technologies such as laser welding and automation.

Skills

Manufacturing engineering

Quality engineering

GMP knowledge

Automation/controls

Root-cause investigation

Job description

Integrated Services For Productivity & Validation, Inc | Contract

Dorado, Puerto Rico | Posted on 02/12/2026

We provide the industry with a platform of solutions designed to their actual needs. We share and implement leading edge technology and methods that exceed customer expectation and deliver a one‑stop provider of services focus on the well‑being of the company and the employees.

Job Description

The Process Development Engineering contractor 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).

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.

Requirements

Please review the requirements, please include GPA in resume

• 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.