2023-Present
Director of Engineering
Delee Corp
(www.delee.co)
Noleus Technologies is a Houston-based medical device company focused on improving post-operative recovery by developing innovative solutions that reduce intestinal swelling and restore normal bowel function after abdominal surgery, addressing one of the leading causes of extended hospital stays and healthcare costs.
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Design for Manufacturing and Assembly (DFMA): Led DFM initiatives and established the first ISO 13485-compliant assembly lines for Noleus core products, achieving high-quality and scalable production.
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Process Validation: Executed IQ, OQ, and PQ protocols to validate manufacturing processes, maintaining full regulatory compliance and reproducibility.
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Design Control Leadership: Oversaw cross-functional engineering teams through all design control phases, ensuring traceability across DHF, DMR, and risk management documentation per ISO 13485 and ISO 14971.
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Verification & Validation (V&V): Directed comprehensive product verification and validation testing to confirm design intent and ensure safety, efficacy, and reliability.
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Supplier and Manufacturing Management: Led technical relationships with authorized converters, component suppliers, and contract manufacturers, ensuring design transfer and production readiness.
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Cross-Functional Collaboration: Partnered closely with Quality, Regulatory, and Clinical Affairs teams to ensure alignment across the product lifecycle and submission requirements.
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Strategic Leadership: Defined and executed engineering strategy, technical roadmaps, and budgets to meet company milestones.
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Regulatory Compliance: Directed engineering efforts to align the Noleus core products with the FDA 510(k) pathway, ensuring design controls and documentation readiness for market submission.
