Job Description

As a Senior Manufacturing Engineer , you’ll play a key role in advancing diagnostic production processes, ensuring top quality, efficiency, and automation excellence.

Key Responsibilities:

• Design, install, and qualify new automated filling and packaging equipment
• Define equipment specifications and support validation (IQ/OQ/PQ)
• Lead cross-functional projects to improve throughput, yield, and equipment uptime
• Develop and maintain manufacturing documentation (SOPs, records, specs)
• Drive process optimization, cost reduction, and continuous improvement initiatives
• Ensure compliance with cGMP , ISO , and FDA standards

Qualifications:

• Bachelor’s or Master’s in Engineering or related field
• 4–6+ years of experience in a cGMP manufacturing or medical device/diagnostics environment
• Hands-on experience with automation, packaging, and equipment validation
• Strong knowledge of design transfer , process optimization , and cross-functional collaboration
• Experience with injection molding , adhesive bonding , or surface treatments a plus

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