Business Unit: Diagnostics
Requisition Number: 240001
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: No
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
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape
This position will be responsible for the implementation of the standardization strategy for each individual ADVIA Centaur and Atellica product.
This person will be a part of a small team focused on developing standardization strategies for existing products. This includes developing Anchor and Gold Standards and MDPs when not in existence. In addition, this position will focus on modification to the value assignment process to align with new control system requirements. The position will create and execute the design of experiments, as well as coordinate data analysis, and write internal reports and documentation. This person will coordinate and perform material and process validations following written protocols, and prepare validation and/or test result reports. This person will work with serum and other biological fluids of human and animal origin.
- Leads and participates in investigations of technical issues associated with formulation and testing of Control Systems materials.
- Writes compliant documentation associated with investigations, data analyses, and experimental conclusions.
- Works in the laboratory running Atellica, Centaur, and CP instrumentation with serum and other biological fluids of human and animal origin.
- Coordinates and carries out investigations and implements corrective and preventive actions (CAPA).
- Creates and participates in the design of experiments (DOE) to troubleshoot manufacturing issues.
- Coordinates and performs material and process changes following written protocols.
- Acts as SME for product and process knowledge (immunoassay design, design change process, etc.)
Required Knowledge/Skills, Education, and Experience:
- Extensive experience with running/designing/troubleshooting immunoassays.
- Extensive experience with automated immunoassay analyzers and/or ELISA and chemiluminescent technology
- Demonstrated ability to interpret data, and to troubleshoot and resolve technical issues.
- Strong work ethic, excellent written and communication skills, and the ability to work independently.
- Lead change or development projects to completion.
- Must be flexible and demonstrate the ability to quickly change priorities to meet business needs.
- Proficiency with Microsoft Office
BS in Medical Technology, Immunology, Biochemistry, Biology, Chemistry.
4+ Years job related experience