Design Engineer

• Drive new product launches from design through full production readiness.
• Evaluate customer drawings, specifications, and technical requirements for manufacturability.
• Coordinate efforts across Engineering, Quality, Supply Chain, and Operations.
• Establish production processes, workflows, work instructions, and manufacturing standards.
• Lead validation activities including IQ/OQ/PQ, equipment qualification, FAT/SAT, and test method verification.
• Support PFMEA, process capability studies, and first article inspections.
• Execute pilot builds, troubleshoot startup issues, and improve quality, yield, and efficiency.
• Train production personnel and manage the transfer of validated processes to Operations.

• Bachelor’s degree in Engineering, Manufacturing, Industrial Engineering, or related discipline.
• 3 years of experience in NPI, manufacturing engineering, or process implementation.
• Experience launching products in regulated manufacturing environments.
• Knowledge of validation protocols, process documentation, and root cause analysis.
• Familiarity with PFMEA, Control Plans, DOE, Lean Manufacturing, Six Sigma, and statistical process analysis (Cpk/Ppk).
• Strong project management, communication, and cross-functional collaboration skills.

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