Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 227423
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 25%
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
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
Are you looking for a new challenge? Then join us and help us build a new manufacturing plant in China.
The SME project manager is responsible for building, developing and leading a multi-site, cross-functional team to ensure that timelines and project milestones of DRACO Master and Wave schedules are met.
Key purpose of this position is to lead the risk management and design history files activities and provide support to the SME, Wave Lead and Element Teams to drive MFG Transfer to China.
The SME project manager will work closely with members of Technology Transfer WAVE Element Teams, SME Element teams and DRACO Core team and China based teams and will be responsible for leading and coordinating project activities, defining schedules, and managing project resources, risks and opportunities.
Tasks include: Leading a w ave transfer e lement team and c oordinate Tech Transfer SME activit ies as the WAVE and Master schedule requires. Develop strategies, drive decisions, develop plans and implement actions that will drive on-time completion of DRACO Master and Wave deliverables. Summarize and resolve project challenges independently , prepare reports and presentations and present/report in concise and clear manner to Core team and China team as needed. Demonstrate and applies comprehensive knowledge of IVD industry regulations and FDA guidelines and practices. Compliance and Quality are MUSTS.
Individual will be specifically responsible for:
Drive a Wave Transfer Element Team
Develop and utilize tracking tool s for issues/projects/timelines
Interact with TECTRN SMEs to resolve project roadblock and identify savings opportunities
Interact with other DRACO functions to resolve CFDA/compliance issues
Effectively build and manage relationships with project stakeholders
Communicate issues/projects status on regular basis to DRACO Core team and SME team lead.
Required Knowledge/Skills, Education, and Experience
Understanding of the assay architecture and design of immunoassays.
Be able to give presentations in a clear and concise manner.
Good understanding of FDA and IVD industry regulations.
Previous exposure to Design controls and risk management activities.
Demonstrate ability to analyze problems in a structured and systematic manner.
Ability to multi-task and to support multiple project teams in cross functional settings.
Excellent organizational, oral and written communication skills.
Proficient in Microsoft Office applications.
BS in project management, chemistry, biology or biological sciences, with 6-10 yrs industry experience, or MA/MS with 3-6 yrs industry experience
Preferred Knowledge/Skills, Education, and Experience
Prior experience with the Advia Centaur product line is a plus
Fluent in Chinese-Mandarin is a plus