Senior Manufacturing Engineer, Operations Systems

🕒 vor 17 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $113.000 - $157.000 / Jahr

⏰ Vollzeit

🟠 Senior

⚙️ Operations

Jetzt Bewerben

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Penumbra, Inc.

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2004

⚕️ Krankenversicherung

🧬 Biotechnologie

Healthcare Insurance • Biotechnology • Medical Devices

Penumbra, Inc. ist ein globales Medizintechnikunternehmen, das sich auf die Entwicklung innovativer Technologien zum Wohle von Patientinnen und Patienten weltweit konzentriert. Spezialisiert auf die Herstellung von Medizinprodukten für neuro- und vaskuläre Erkrankungen bietet Penumbra unter anderem Thrombektomie-Systeme, Embolisationskatheter und MRT-kompatible Systeme an. Das Unternehmen treibt die Patientenversorgung mit Next-Generation-Softwarelösungen wie Lightning Flash 2. 0 voran – entwickelt für die schnelle Entfernung von Blutgerinnseln und die Behandlung der Lungenembolie. Penumbra setzt sich dafür ein, die Ergebnisse bei Erkrankungen wie Schlaganfall, Hirnaneurysma und Herzinfarkt zu verbessern – gestützt durch klinische Evidenz und wachstumsorientierte Investorenstrategien.

Beschreibung

• The Sr. Manufacturing Engineer, Operations Systems provides leadership in the engineering, design and development of new products or changes to existing products, processes, and equipment. • Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing development of neurovascular devices. • Provide engineering support on existing devices for manufacturing. • Create and execute an integrated cross-functional project plan. • Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope. • Develop new processes for medical devices and components. • Execute tasks independently and does not require assistance nor guidance. • Think strategically within scope. • Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally. • Lead cross-functional team to plan and implement changes and improvements to operational systems and processes. • Lead identification, discussion, and mitigation of project risks to successful completion of tasks and activities. • Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports. • Perform research and integrate new technologies into existing and future products and processes. • Solve practical problems encountered. • Create and modify product design specifications. • If in a supervisory position, select, manage, train, and develop staff.

🎯 Anforderungen

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree and 4+ years relevant engineering experience, or an equivalent combination of education and experience • Master’s degree preferred • Detailed knowledge of GMP/Quality System Regulations and clean room environment practices • Demonstrated knowledge of engineering and scientific principles • Engineering experience in a manufacturing environment recommended, medical device industry preferred • Excellent written, verbal and interpersonal communication skills required • Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired • Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required • High degree of accuracy and attention to detail • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.