Medical Device Development Engineer Job in Texas (TX), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Medical Device Development Engineer job in Fort Worth

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Novartis Pharmaceuticals jobs
Texas (TX), Fort Worth
Job Code:  238335BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  Texas (TX)
City:  Fort Worth
Map: 
09/05/2018

Description
Leading and driving technical development activities of established and novel drug delivery device/combination products with a cross-functional team. The activities range from early clinical phase up to commercialization and production scale up. Outstanding project management and inter-personal skills and a strong technical background in medical devices are essential, in order to support, monitor and challenge internal and external development partners.
Responsibilities
•Thorough project planning and project leadership
•Ensuring compliance with internal quality requirements
•Leading the definition of product requirements for delivery systems, e.g. drug/device combination products and medical devices
•Ensuring a high quality design history file; leading and authoring technical documentation
•Planning, leading and managing Risk management, Design Verification activities
•Monitoring Human Factors Engineering activities
•Transfer of Design History File to production
•Leading and/or manage the collaboration with external and internal development partners and stakeholders:
-Monitor and communicate work progress according to plan
-Monitor, support and challenge technical development as well as testing and verification work
-Monitor development and implementation of manufacturing processes
-Monitor CapEx and COGS
•Provide primary packaging and device expertise in broader cross-functional drug product development teams. Proposing, evaluating and challenging technical solutions
•Supporting and coordinating the manufacturing of clinical material and the production scale up
•Supporting cross functional project teams in the development, review and submission of regulatory dossiers
Minimum requirements
•Master's degree in University level Engineering education
•Fluency in English language is required.
•Excellent technical writing skills for drug/device combination products and medical device documentation, including Design Control process and other applicable regulatory, QA and GMP aspects
•Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive and succession to Medical Devices Regulation, ISO)
•Considerable experience in project / program management of complex projects with multiple suppliers
•Minimum 5 years' experience in medical device industry
•Analytical problem solving skills
•Ability to work in a matrix organization, as part of or leading teams cross functionally. Encouraging collaboration, high performance, and quality with a speak up mindset

Desirable

•Good understanding of pharmaceutical development and manufacturing in general
•Mechanical engineering in general
-Product design for injection molding/design for manufacture
-Connectivity and assembly technology for large volume production
-Rapid prototyping / mock design for early stage evaluation
-Test and verification, incl. development of methods and equipment
•Experience in primary packaging
•General understanding of Human Factors Engineering and Risk management
•Used to work with designers and product managers
•Know-how in microfluidics and/or powder handling
ref: (238335BR)
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