Senior Process Development Engineer – Medical Devices (FDA)

Avante Engineering LLC.; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Avante Engineering LLC seeks a Process Development Engineer to support development, validation, and implementation of new manufacturing processes, including equipment validation, documentation generation, process optimization, and cross-functional collaboration. The role encompasses IQ/OQ/PQ activities, designing inspection systems, documenting equipment procedures, and managing cross-functional projects.

Proficiency with DOE, FMEA, CAPA, and root-cause analysis is essential for ensuring patient

Qualifications

• 5-7+ years in manufacturing or quality engineering in FDA-regulated environments.
• Strong 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 protocols and reports.
• 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

Automation controls

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in Electrical/Mechanical Engineering

Tools

Automation equipment

Job description

Avante Engineering LLC seeks a Process Development Engineer to support development, validation, and implementation of new manufacturing processes, including equipment validation, documentation generation, process optimization, and cross-functional collaboration. The role encompasses IQ/OQ/PQ activities, designing inspection systems, documenting equipment procedures, and managing cross-functional projects.

Proficiency with DOE, FMEA, CAPA, and root-cause analysis is essential for ensuring patient