Senior Technical Steward Medical Devices

Job Description Summary

The Senior Technical Steward Medical Devices provides his knowledge in medical device manufacturing and all related manufacturing activities like molding and device assembly to the global and local stakeholders. This role is pivotal in driving technical excellence, ensuring compliance, and advancing Novartis device strategy through deep process knowledge, supplier management, and cross-functional collaboration.

 

Job Description

Senior Technical Steward Medical Devices

Location – Hyderabad #LI Hybrid

About the Role:

The Senior Technical Steward Medical Devices provides his knowledge in medical device manufacturing and all related manufacturing activities like molding and device assembly to the global and local stakeholders. This role is pivotal in driving technical excellence, ensuring compliance, and advancing Novartis device strategy through deep process knowledge, supplier management, and cross-functional collaboration.

Key Responsibilities:

• Own and maintain deep knowledge of specific medical device manufacturing process technologies, including pilot scale operations, scale-up/down activities, and Design of Experiments (DoE). 

• Act as an expert in molding of device constituent parts; oversee injection molding tool design, qualification, life-cycle management, and performance monitoring at external manufacturing sites. 

• Provide expertise in autoinjector device and sub-assembly manufacturing processes to ensure robust and compliant operations. 

• Support Technical Steward in device development projects by assessing scalability of new devices transitioning from development to commercial manufacturing phases. 

• Advise Technical Stewards on initial qualification and life-cycle maintenance of injection molding machine toolsets and related activities to advance Novartis’ Device Strategy. Ensure accurate and thorough review of technical documentation packages during development handover by applying your technical expertise. 

• Ensure adherence to current industry practices, regulatory and quality guidelines, and standards for injection molding and component assembly; apply this knowledge in line qualification and product validation activities. 

• Leverage understanding of the molding and assembly supplier landscape to maintain and transform it into a future-ready, robust supplier network. 

• Deliver fundamental technical knowledge through regular training and education programs for Process Experts and Operators. Spearhead process and operational excellence initiatives to enhance combination product quality, reliability, and reduce risks and costs. 

• Collaborate with technical development teams, other sites, and the global MS&T network to enable effective transfer of technical knowledge. Conduct technical feasibility trials to support process improvements and implementation of new manufacturing technologies. 

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Essential Requirements

• Exposure to ISO 13485, 21 CFR Part 4 and FDA validation guidelines. 

• Bachelor’s or Master’s degree in Mechanical Engineering, Chemical Engineering, or a related discipline. 

• Approximately 10 years of experience in combination products development or operations. 

• Previous experience in pharmaceutical, biotechnology or engineering environments. 

Strong working knowledge of GMP manufacturing principles.

Desirable Requirements

• Proven experience in outsourcing and managing strategic device partners. 

• Demonstrated project management experience in combination products. 

• Fluency in English (written and spoken) is essential. 

• Advanced understanding of mechanical design principles, assembly process expertise and design standards, including proficiency in CAD software (e.g., SolidWorks) for e.g. injection device development and manufacturing). 

• Strong interpersonal and negotiation skills, with a proven ability to build effective relationships and influence outcomes. 

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

 

Skills Desired

Applied Statistics, Applied Statistics, Assembly Language, Back-End Development, Biotechnology, Chemical Engineering, Chemistry, Design Development, Electronic Components, General Hse Knowledge  , Incentive Program, Including Gdp, Knowledge Of Capa, Knowledge Of Gmp, Leadership, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Npd (New Product Development), Process and Cleaning Validation, Process Control, R&D (Research And Development), Root Cause Analysis (RCA), Software Development, Software Engineering {+ 1 more}