Job Description

Job Description

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:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field .
• 5+ years of experience in process engineering within a medical device (Class III preferred) or similarly regulated manufacturing environment.
• Proven experience with IQ/OQ/PQ validations and process documentation.
• Strong understanding of FDA regulations, ISO 13485, and GMP principles .
• Demonstrated success leading continuous improvement or lean manufacturing projects.
• Excellent analytical, communication, and project management skills.
• CAD proficiency (SolidWorks or equivalent) preferred.
• Must be self-motivated, proactive, and capable of driving initiatives independently .

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