The successful candidate will participate in a wide variety of semi-complex technical assignments associated with the manufacturing of Diabetes diagnostic tests. The position involves systematic troubleshooting of complex reagent manufacturing formulations and processes both in individual and team-based projects. The incumbent will be responsible to help write and execute validation plans, lead root-cause analysis efforts, and identify/implement process/equipment improvements. This person must be highly competent at planning/executing complex lab studies and utilizing specialized testing techniques. Must also be able to analyze, interpret, and present complex data for review and summarize results in a technical report. The medical device industry is highly regulated, and the candidate must be able to support compliance with ISO and FDA requirements.
Major tasks and responsibilities:
· Conduct 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 paper-based reagent production.
· Lead cross-functional manufacturing support team and mentor junior biochemists.
· Provide technical support for OEM product/process investigations and improvements; customer complaint investigations; and customer service support information requests.
· Lead root-cause investigations and drive implementation of those solutions to improve reagent performance and manufacturability.
· Able to design complex 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.
· Effectively communicate (oral and written) work progress in both intra- and inter-departmental team forums.
· 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 or Masters in Biochemistry or Chemistry.
· Min 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 technical reports and testing protocols per approved department and site procedures.
· Must be well versed in Office Applications, particularly Excel and Access; experience in 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 and CAPA Investigator experience
· Demonstrates good laboratory and manufacturing practices
· Working knowledge of manufacturing process performance trending
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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