When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
The Senior Manufacturing Scientist works in a production environment where a variety of scientific instruments are produced. Involvement in sustaining, failure analysis, and new product development are key components of this position.
With an ownership mindset, the Senior Manufacturing Scientist works closely with suppliers, production, and design & field engineering to provide technical support for the scientific instruments manufactured at the San Jose and Supplier manufacturing sites.
With the goal of improving overall quality, the Senior Manufacturing Scientist sustains existing product lines, supports New Product Introduction (NPI) activities from manufacturing pilot phase through production, and conducts failure/root cause analysis in a lean-manufacturing and ISO/FDA-regulated environment.
Reporting to the Manufacturing Engineering Manager, this role is tasked to ensure that designs are robust by providing feedback in the experience and the analysis of non-conforming material and participating with the product development team as a manufacturing representative. For accuracy, the Senior Manufacturing Scientist will review designs and drawings, work instructions, BoMs, etc., and as required, make changes to or create documentation used by Thermo and our suppliers.
Essential Duties and Responsibilities:
Troubleshoot and solve problems at a component and system level
Conduct failure analysis of systems, products, and parts
Perform New Product Introduction (NPI) support on systems, sub-systems, and software.
Transition the technical aspects of NPI activities from design to manufacturing and train Technicians and Manufacturing Engineers on how to manage differences/changes.
Conduct failure analysis in support of CAPA and customer issues.
Review, modify, and approve ECOs for manufacturing medical device (MD) site.
Create, maintain, and train Technicians on work instructions and process documents.
Perform and maintain risk analysis and mitigation.
Develop protocols for process validation.
Maintain validation files and support any new or re-validation activities.
Work with supply base and local Supplier Quality Engineering (SQE) team to ensure suppliers meet expectations and requirements and address SCARs and other corrective actions.
Review and manage non-conforming material rejections from production.
Design and implement test equipment as needed.
Minimum Requirements and Qualifications:
BS in Engineering, Physics, Chemistry, or related discipline required, with MS/PhD in Physics or Chemistry preferred.
Demonstrated understanding and experience of RCCM methods
Hands-on knowledge in design, development and engineering of complex instrumentation is required.
Use of general electrical test equipment (DVM, oscilloscope, etc) and basic understanding of mechanical and electrical drawings.
Strong instrumentation design and troubleshooting ability including experience in technical troubleshooting of complex instrumentation.
Must be able to understand technical engineering documentation and the change control process including risk analysis review.
Must be a self-starter and be able to work alone and in multi-disciplinary teams
Excellent communication skills required with the flexibility to attend occasional calls outside of normal work hours.
Knowledge of chromatography and mass spectrometry theory and hands-on experience with components (such as liquid chromatography, electromagnetic fields, ionization sources, mass analyzers, RF systems, electrometers, and charged particle detectors) are strong plusses.
Familiarity in one or more industry standard computer languages or firmware (Lua, Python, C#, C++, etc.)
Experience in medical device manufacturing and working in a regulated environment (ISO 9001/13485 and 21CFR820). SAP experience is a plus. Advanced knowledge of Microsoft Excel, Word, and Project required.
10-15% travel to supplier and customer sites as needed.
Ability to balance multiple priorities and execute with speed.
Demonstrate Thermo Fisher Scientific values – Integrity, Intensity, Innovation and Involvement.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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