Siemens Careers

MF-Project Mgmt Spec 3 (Tech)

East Walpole, Massachusetts
Project Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 226005
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

Division Description
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


Job Description:

Position Overview
 
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: Lead the technology transfer activities to develop design history files and risk management files that are compliant with the cFDA regulations. Support DRACO Core team, Wave transfer Element team and Coordinate Tech Transfer SME activity as 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 problems, 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.
 
Responsibilities
Individual will be specifically responsible for:
  • Drive completion of risk management and design history files activities
  • Develop tracking tool 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
  • Support other activities within the SME element teams (PTR, PPE, clinical trials, and type testing)
  • 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.
  • Have experience in design control, risk management activities and CAPAs.
  • Be able to give presentations and partake in high level reviews 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 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


Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.