Process Development Engineer — Medical Device Manufacturing

Techengpr; Dorado (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

Techengpr is seeking an experienced Process Development Engineer to support development, validation, optimization, and implementation of manufacturing processes in a regulated environment.

You will collaborate with cross-functional teams to qualify equipment, generate documentation, and support new product introductions while ensuring compliance with FDA and quality systems. This role emphasizes problem solving, continuous improvement, and process innovation in a fast-paced setting.

Qualifications

• Bachelor's degree in mechanical or electrical engineering.
• 5–7 years of manufacturing or quality engineering in FDA-regulated industry.
• Experience in Medical Devices, Pharmaceutical, Biotechnology, or Diagnostics manufacturing.
• Proficient with IQ/OQ/PQ, DOE, PFMEA, CAPA, and RCA.
• Knowledge of 21 CFR Part 820, GMP, ISO 13485.

Responsibilities

• Lead and support equipment qualification activities including IQ, OQ, PQ, and PPQ.
• Develop validation protocols, reports, and Master Validation Plans.
• Design and implement in-process and receiving inspection systems for new products and manufacturing processes.
• Prepare technical documentation including equipment evaluations, PM procedures, calibration procedures, and manufacturing work instructions.
• Manage process development projects from concept through implementation.
• Partner with Manufacturing, Quality, Engineering, Automation, and Operations teams to ensure project success.
• Apply engineering tools such as DOE, PFMEA, Risk Analysis, and Root Cause Investigations.
• Support process characterization, optimization, troubleshooting, and continuous improvement initiatives.
• Work with advanced manufacturing technologies (laser welding, heat bonding, injection molding, vision inspection, PLC/Servo systems, pneumatics, sensors).
• Support NPI and process scale-up activities.
• Ensure compliance with FDA regulations, GMP, and company quality systems.

Skills

DOE

PFMEA

CAPA

Root Cause Analysis

Process Validation

Equipment Qualification (IQ/OQ/PQ)

Risk Analysis

Project Management

Cross-Functional Collaboration

NPI Support

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Electrical Engineering

Job description

Techengpr is seeking an experienced Process Development Engineer to support development, validation, optimization, and implementation of manufacturing processes in a regulated environment.

You will collaborate with cross-functional teams to qualify equipment, generate documentation, and support new product introductions while ensuring compliance with FDA and quality systems. This role emphasizes problem solving, continuous improvement, and process innovation in a fast-paced setting.