Process Development Engineer

About This Role

This is a mid-level Process Development Engineer role focused on supporting a rapidly growing medical device business unit by leading process validations, equipment qualifications, and manufacturing line setup. The position also involves supporting ongoing remediation efforts and continuous process improvement to meet aggressive volume increases.

Responsibilities

• Lead and execute process validations and equipment qualifications (IQ/OQ/PQ) for new and existing manufacturing lines
• Support line setup, commissioning, and validation of existing processes to meet increased production demand
• Provide hands-on operations support, with ownership areas that may shift as business priorities evolve
• Support ongoing remediation activities, including revalidations and corrective actions
• Identify and execute process improvement initiatives using DMAIC and Lean methodologies
• Develop and maintain validation documentation in compliance with FDA QSR and ISO 13485

Requirements

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field)
• 2-6 years of experience in process development or manufacturing engineering within the medical device industry
• Strong experience with process validations and equipment qualifications
• Hands-on experience supporting manufacturing operations
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field)
• 2-6 years of experience in process development or manufacturing engineering within the medical device industry

Skills

* Required skills