Process Development Engineer

Responsibilities

• Support IQ/OQ/PQ and process performance qualification activities, including the development of validation protocols, reports, and master validation plans
• Design and develop in-process and receiving inspection systems for new components and processes
• Generate equipment documentation such as evaluations, PM/calibration procedures, and manufacturing instructions
• Manage process development projects from concept through implementation while collaborating with cross-functional teams
• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes
• Work with advanced technologies including laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors)

Requirements

• 5–7+ years of experience in manufacturing or quality engineering within an FDA-regulated environment (medical devices, pharma, diagnostics, or 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

About the Company

Avante Engineering LLC was founded in 2019 with a vision centered on delivering a personalized approach to engineering and technical services. We provide expert consultation, project management solutions, and technical services to help our clients achieve project excellence.