Process Development Engineer

Mirus Consulting Group; Dorado (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Mirus Consulting Group is seeking a Process Development Engineer to drive the development, validation and implementation of new manufacturing processes in our FDA‑regulated environment. You will lead qualification activities, develop protocols and collaborate with cross‑functional teams to optimize production.

Candidates bring 5–7+ years in manufacturing or quality engineering, strong knowledge of 21 CFR Part 820, GMP and ISO 13485, and hands‑on experience with automation, DOE and robust change

Qualifications

• 5–7+ years in manufacturing 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 validation 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).

Skills

DOE

FMEA

CAPA

Root cause analysis

Process validation

Cross-functional collaboration

Quality systems

Tools

Automation systems

Vision systems

PLC/Servo/Pneumatics

Laser welding

Heat bonding

Injection molding

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.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.