MF-Project Mgmt Spec 3 (Tech)
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%
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
- 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.
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