Process Engineer

Position Summary :

The Process Engineer will take ownership of manufacturing and packaging process leadership—evaluating current systems, identifying areas for improvement, and driving initiatives that enhance efficiency, quality, and compliance. This role requires a self-starter with strong process validation experience, a continuous improvement mindset, and the confidence to lead cross-functional initiatives in a regulated medical device environment.

Key Responsibilities :

• Lead process improvement efforts across manufacturing and packaging operations to optimize quality, performance, and throughput.
• Assess current processes, identify root causes of inefficiencies, and implement data-driven solutions.
• Plan, execute, and document IQ / OQ / PQ validations in compliance with FDA and ISO 13485 requirements.
• Partner with Regulatory and Quality teams to evaluate process changes and ensure full regulatory compliance.
• Provide engineering support for process changes related to new product introductions, packaging redesign, and manufacturing transfers.
• Use CAD tools to support packaging redesigns, equipment layouts, and process documentation.
• Lead cross-functional teams in implementing continuous improvement and lean manufacturing initiatives.
• Prepare and maintain technical documentation, including protocols, reports, and risk analyses.

Qualifications :