Business Unit: Laboratory Diagnostics
Requisition Number: 234404
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
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
- 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.
- May lead a team or directly 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.
- Review historical data to prepare regulatory submission required 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 write the technical sections of regulatory dossier as required by the China manufacturing project.
- Lead or participate in the design verification activities; troubleshoot and solve technical issues.
- Support Risk Management activities such as developing dFMEA and pFMEA.
- Participate in training of Chinese colleges to support the China Technical operations group investigations into manufacturing issues.
Collaborate with other team members and support cross functional 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, troubleshoot and resolve the technical issues.
- Strong work ethic, be highly motivated, and work independently with high energy.
- Strong leadership skills, excellent written and communication skills.
- Strong statistical skills (ANOVA, linear regression and t-test) and proficiency with statistical software (Minitab, SAS).
- Proficiency with Microsoft Office Applications.
- Advanced degrees preferred.
- Knowledge and experience in IVD product registration.
- Experience with immunoassays, including automated immunoassay analyzers, ELISA and chemiluminescent technology.