Business Unit: Laboratory Diagnostics
Requisition Number: 231001
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
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
- May lead a team or directly perform technical studies including feasibility, characterization, verification, and validation studies as required by the China manufacturing project.
- Responsible for planning and designing of technical studies, develop and write protocol and reports.
- Contribute to developing PTR/PPE strategies and write the technical sections of regulatory dossier as required by the China manufacturing project.
- Lead or participate in the design verification activities to 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.
- Participate in cross-functional team to provide technical support to prepare DHF, materials list, risk assessment and other documents required for the technology and manufacturing transfer.
- Coordinate and perform data analysis, summarize testing results, and present studies in cross-functional teams.
- Participate in training of Chinese colleges to support the China Technical operations group investigations into manufacturing issues.
Collaborate with other team members and Departments for technology transfer and cross functional, multi-sites team activities.
- BS, MS or PhD in Medical Technology, Biology, Biochemistry, Immunology, Life Science or related fields.
- 10+ 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.
- Strong leadership skills and excellent written and communication skills, and the ability to work as a team leader.
- Proficiency with Microsoft Office Applications and statistics software (Minitab, SAS).
- Advanced degrees preferred.
- Knowledge and experience in IVD product registration.
- Experience with immunoassays, including automated immunoassay analyzers, ELISA and chemiluminescent technology.