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Project Manager -- Medical Device -- Technical

East Walpole, Massachusetts
Project Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 225828
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:

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.
 

Process Review/Risk Management/Test Method Validation SME

 
Position Overview
Key leadership position to support Process Review Template (PRT), process failure mode effect analysis (pFMEA), test method validation (TMV) activity for project DRACO across product waves.
 
Key purpose of this position is to be the Process Review/TMV/Risk management Subject Matter Expert (SME) for the DRACO Technical Transfer Group.
 
Tasks include: Lead the efforts to develop PRT/PFMEA, Risk management and TMV strategy across all products and Waves. Build and develop a cross-functional and multi-site manufacturing team to coordinate Process Review/TMV/Risk management  activities. Coordinate and lead Process review SME activities as WAVE schedule requires. Interact with other functional areas on DRACO Core team as needed. Compliance and Quality are MUSTS.  Seek advice and guidance on non-routine or problem areas from others.  Identify problems as they occur, work with other functions within project Draco and across manufacturing sites to develop strategies and escalate as necessary. Propose solutions and drive actions to resolve roadblocks and obstacles as they arise. Summarize problems and present/report in concise and clear manner to Core team and others as needed.  Deliver status updates, manage schedule and lead cross-functional teams to complete PRT/TMV and Risk management deliverables.  
 
Demonstrates and applies comprehensive knowledge of IVD/FDA regulated field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues.
 
Responsibilities
Individual will be specifically responsible for:
  • Own coordination and development of PRT/PFMEA strategy for DRACO Tech Transfer
  • Own coordination and development of TMV strategy across DRACO Tech Transfer
  • Own coordination of Risk management process
  • Own and drive Template development of Reports, Plans, PRTs as needed
  • Drive Process review activities according to Wave schedule
  • Track progress of requested and assigned tasks and report to SME lead and core team as needed
  • Drive risk management activities per master schedule
  • Communicate status updates of PRT/PFMEA/TMV and risk management activities on a regular basis
  • Assist with training and Transfer of Tech Transfer responsibilities to China personnel
  • Prepare presentations and report in a clear and succinct manner to SME lead and Core team.
Required Knowledge/Skills, Education, and Experience
  • BS/BA in chemistry, biology or biological sciences, with 10+ yrs industry experience, which should include experience managing complex projects 
  • Team leadership skills and project management skills  and ability to lead multi-site, cross-functional teams
  • Design Control Experience including: Risk management, Design change, Verification, Validation
  • Manufacturing Transfer experience.
  •  Proven record of producing written reports (i.e. published papers, company reports, etc.)
  • Demonstrated effective written and oral communications skills
  • Ability to function in a fast pace, changing, and high-impact position, with deadline and resource limitations
  • Capacity to achieve desired outcomes based on ability to facilitate and negotiate desired results
  • Experience working in a FDA regulated environment
     
Preferred Knowledge/Skills, Education, and Experience
  • Prior experience in IVD and cFDA regulated industry
  • Understanding of immunoassay design and trouble shooting
  • Prior experience with the Advia Centaur product line a plus
 

 

 

 

 

 



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