Staff Engineer - Medical Packaging & Process Optimization

Terumo Neuro; Aliso Viejo (CA); Hybrid; USD 117.000 - 153.000; Vollzeit

Zusammenfassung

Terumo Neuro in the United States is seeking a packaging engineer to lead and manage complex packaging development, validation, and transfer projects for medical device products. The role includes drafting specifications, supporting DFMEA/PFMEA, and ensuring compliance with ISO 11607, FDA, and internal QMS.

You will collaborate with Manufacturing, Quality, Regulatory, R&D, and Supply Chain to resolve packaging-related issues, drive process improvements, and support new product introductions and

Aufgaben

• Lead and manage packaging development, improvement, and transfer projects for medical device products.
• Support sterile and non-sterile packaging systems for new products, product changes, line extensions, and sustaining engineering activities.
• Develop, review, and maintain packaging documentation including packaging specifications, BOM drawings, test methods, and validation protocols.
• Contribute to design control deliverables for packaging design and process (e.g., DFMEA and PFMEA), design reviews, and change management processes.
• Draft, execute, and report packaging validations in accordance with ISO 11607, FDA, and internal Quality Management System requirements.
• Support audits and inspections of packaging processes (internal and external).
• Collaborate with Manufacturing, Quality, Regulatory, R&D, and Supply Chain to resolve packaging-related production and quality issues.
• Execute packaging validation and verification activities including packaging integrity, transportation simulation, and accelerated and real-time aging studies.
• Support new product introductions, product changes, and transfers by defining packaging strategies, validation plans, and timelines.
• Analyze data and implement improvements to ensure robust, repeatable, and compliant packaging processes.
• Confer with internal teams and external suppliers to evaluate packaging materials, components, and process changes.
• Support packaging transfer and supplier qualification activities across manufacturing sites.
• Investigate and resolve packaging-related nonconformances, deviations, and engineering changes using structured root-cause analysis tools.
• Drive continuous improvement initiatives, such as manufacturing automation, sustainability, integration of Unique Device Identification (UDI) or digital elements (e.g. RFID) and risk reductions.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Jobbeschreibung

Terumo Neuro in the United States is seeking a packaging engineer to lead and manage complex packaging development, validation, and transfer projects for medical device products. The role includes drafting specifications, supporting DFMEA/PFMEA, and ensuring compliance with ISO 11607, FDA, and internal QMS.

You will collaborate with Manufacturing, Quality, Regulatory, R&D, and Supply Chain to resolve packaging-related issues, drive process improvements, and support new product introductions and