The successful candidate will participate in a wide variety of semi-complex technical assignments with respect to systematic troubleshooting and support of manufacturing and supplier issues for DCA Vantage and DCA Atellica immunoassay diagnostic tests. The incumbent will be responsible for conducting customer complaint investigations, supporting the control charting process for DCA production reagents as well as writing and executing validation plans. Other duties include participation in root-cause analysis efforts and aiding in identifying process/equipment improvements as well as other testing as directed. This person must be highly competent in bench-scale solution preparation and willing to learn specialized testing techniques. Must also be able to prepare, analyze, and present coherent data for review and summarize results in a technical report. The medical device industry is highly regulated, and the candidate must be able to function and support the requirements of the regulations.
Major tasks and responsibilities:
· Conduct root-cause analysis and customer complaint investigations.
· Support reagent manufacturing control charting process for DCA Vantage product line.
· Participate in validation and verification activities to ensure project completion within expected parameters and time frame.
· Design and conduct experiments to identify process issues related to undesirable reagent or manufacturing performance, and identify resolutions for those issues.
· Plan, conduct, analyze, and document experiments necessary to improve manufacturing process capability and reduce costs associated with immunoassay reagent production.
· Work with Product Support technical leaders to collect and analyze reagent and instrument performance data necessary for product/process improvements; customer complaint and problem investigations; and Marketing/Global Service and Support use.
· Able to design experiments, execute test protocols, and analyze/interpret their results.
· Apply principals of lean manufacturing and support continuous improvement activities to meet quality, cost and supply requirements.
· Must be able to verbally communicate clearly and directly with colleagues and provide well-written, coherent progress updates, validation documents, study protocols, and technical reports.
· Participate in supplier and internal audits; able to interact effectively with key suppliers.
· Preferred Bachelors in Chemistry; will consider degree in other science or engineering, with a concentration in Chemistry.
· 2 – 5 years’ experience, preferably in a medical device or related industry
· Strength in one or more of the following areas: Clinical Chemistry, Immunoassays, Analytical Chemistry, Biostatistics, Manufacturing Process Capability, and Computer Science.
· Proven experience in successful root cause analysis and resolution of manufacturing or design issues.
· Demonstrated competence in experimental design and data interpretation
· Working knowledge of basic statistics necessary to develop sampling plans and analyze data.
· Able to prepare and fully understand data analysis reports and testing protocols; able to utilize data collection applications in a laboratory setting.
· Must be well versed in Office Applications, particularly Excel and Access; experience in Matlab, SAS, or Minitab desired.
· Some travel (<10%) may be required.
Other characteristics of the successful candidate:
· Very organized, detail-oriented
· Highly self-motivated
· Able to work independently
· Excellent analytical, communication, writing, and problem-solving skills
· Effective and influential in his/her interactions in team-based assignments
· Able to work well with personnel from different departments, and experience levels
· Lean Manufacturing experience
· Demonstrates good laboratory practices
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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