Medical Device Process Development Engineer (Contract)

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

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,