Process Development Engineer

ProQuality Network; Puerto Rico; On-site; USD 85,000 - 115,000; Full time

Job summary

The Process Development Engineer at ProQuality Network in Puerto Rico supports the development, validation, and implementation of new manufacturing processes within the medical devices industry. You will lead IQ/OQ/PQ activities, develop validation protocols, and collaborate across functions to mature concepts into scalable production.

Ideal candidates bring 5–7+ years in manufacturing/quality engineering, strong 21 CFR Part 820, GMP, and ISO 13485 knowledge, and hands-on experience with DOE,

Qualifications

• 5–7+ years in manufacturing or quality engineering in FDA-regulated medical devices or related fields.
• Strong knowledge of 21 CFR Part 820, GMP, and ISO 13485.
• Hands-on experience with DOE, FMEA, CAPA and root-cause investigation.
• Experience with automation, controls, tooling, fixtures, and equipment qualification.

Responsibilities

• Support IQ/OQ/PQ activities and develop validation protocols and reports.
• Design in‑process and receiving inspection systems for new components and processes.
• Generate equipment documentation, evaluations, PM/calibration procedures.
• Lead process development projects from concept through implementation.
• Collaborate with cross-functional teams and apply DOE, PFMEA, and risk analysis.
• Work with laser welding, heat bonding, injection molding, vision systems, and PLC/servo/pneumatics.

Skills

DOE

FMEA

CAPA

Root-cause analysis

Automation/Controls

Project management

Education

Electrical or Mechanical Engineering degree

Tools

Automation equipment

Vision systems

Job description

Title: Process Development Engineer (Medical Devices Industry)

Location: North of Puerto Rico

Positions: 1

12 months contract with onsite work.

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.

Additional Requirements:

• Availability to work onsite.
• Availability to work flexible hours, including regular business hours, nights, and weekends, as required to meet project timelines.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.