East Walpole, Massachusetts
Research & Development
Siemens HealthineersBusiness Unit:
Laboratory DiagnosticsRequisition Number:
United States-Massachusetts-East WalpoleAssignment Category:
Full-time regularExperience Level:
Mid levelEducation Required Level:
Bachelor's DegreeTravel Required:
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
This Biochemist 2 position is at Walpole Technical Operations for the China manufacturing project. The successful candidate will participate in immunoassay Design History File (DHF) gap analysis and mitigation as a technical expert. The position will also participate in the training of Siemens colleagues who will be based in China in order to learn Technical Operation job functions and responsibilities, and will support the China Technical Operations group investigation and troubleshooting into pilot manufacturing issues.
- Work in the cross-functional team to provide technical support for immunoassay Design History File (DHF) gap analysis and mitigation as a subject matter expert.
- Perform technical studies as required by the mitigation plan. Responsible for planning and designing of technical studies, develop and write protocol and reports. Coordinate and perform data analysis, summarize testing results, and present studies in cross-functional teams.
- Contribute to reviewing historical data and writing R&D reports for critical raw materials, reaction systems and manufacturing processes in immunoassays.
- Contribute to developing Product Technical Requirement (PTR) and Product Performance Evaluation (PPE) strategies and writing the technical sections of regulatory dossier as required by the China manufacturing project.
- Participate in the design verification activities and troubleshoot and solve technical issues.
- Work in the laboratory running ADVIA Centaur and Atellica Systems instrumentation with serum and other biological fluids of human and animal origin.
- Support Risk Management activities such as developing dFMEA and pFMEA.
- Participate in the training of Chinese colleges to support the China Technical operations group investigations into manufacturing issues.
Required Knowledge/Skills, Education, and Experience
- BS, MS or PhD in Medical Technology, Biology, Biochemistry, Immunology, Life Science or related fields.
- 6+ Years job related experience.
- Strong background and experience with automated immunoassay analyzers and/or ELISA and chemiluminescent technology.
- Proven ability to interpret data and to troubleshoot and resolve the technical issues.
- Strong work ethic and be highly motivated to work independently with high energy.
- Excellent written and communication skills, and the ability to work as a team leader.
- Proficiency with Microsoft Office Applications, statistical skills (ANOVA, linear regression and t-test) and statistics software (Minitab, SAS).
- Experience in statistical methods for product (process) development, verification and validation is a plus.
Preferred Knowledge/Skills, Education, and Experience
- Advanced degrees preferred.
- Knowledge and experience in IVD product registration.
- Experience with immunoassays, including automated immunoassay analyzers, ELISA and chemiluminescent technology.