Senior Manufacturing Engineering Manager — Medical Devices

Magnolia Medical Technologies; Seattle (WA); Hybrid; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Magnolia Medical Technologies is seeking a Manufacturing Engineering Manager to provide technical leadership for commercial products and outsourced manufacturing partners. The role ensures product quality, manufacturing excellence, regulatory compliance, and continuous improvement across the product lifecycle.

Based in downtown Seattle, onsite with up to 20% travel. Responsibilities include coordinating with contract manufacturers, leading transfers and capacity expansion, and advancing quality

Qualifikationen

• Bachelor's degree in Engineering or related technical field.
• 8-10 years of manufacturing, sustaining, or product engineering experience.
• Experience in sterile, disposable medical device and global contract manufacturing.

Aufgaben

• Technical liaison with contract manufacturers.
• Lead manufacturing transfers, change management and capacity expansion.
• Support supplier sourcing, qualification, audits, process reviews and issue resolution.
• Develop and optimize manufacturing processes; implement DFM/DFA improvements.
• Validate IQ/OQ/PQ and ensure compliance with FDA/ISO 13485.
• Maintain DHF and DMR; lead CAPA and root cause investigations.
• Actively manages intercompany resources and outside vendors for prototype fabrication and validation.
• Provide cross-functional program and project leadership.

Kenntnisse

Project management

Cross-functional collaboration

Problem solving

Quality systems

Statistical methods

Communication

Ausbildung

Bachelor's degree in Engineering

Tools

SolidWorks

Jobbeschreibung

Magnolia Medical Technologies is seeking a Manufacturing Engineering Manager to provide technical leadership for commercial products and outsourced manufacturing partners. The role ensures product quality, manufacturing excellence, regulatory compliance, and continuous improvement across the product lifecycle.

Based in downtown Seattle, onsite with up to 20% travel. Responsibilities include coordinating with contract manufacturers, leading transfers and capacity expansion, and advancing quality