Position Purpose:
Thesuccessful candidate will participate in a wide variety of semi-complex technicalassignments associated with themanufacturing of Diabetes diagnostic tests. Theposition involves systematic troubleshooting of complex reagent manufacturingformulations and processes both in individual and team-based projects. The incumbent will be responsible to helpwrite and execute validation plans, lead root-cause analysis efforts, andidentify/implement process/equipment improvements. This person must be highly competent atplanning/executing complex lab studies and utilizing specialized testingtechniques. Must also be able to analyze,interpret, and present complex data for review and summarize results in atechnical report. The medical deviceindustry is highly regulated, and the candidate must be able to support compliancewith ISO and FDA requirements.
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Major tasks and responsibilities:
• Conductvalidation and verification activities to ensure project completion withinexpected parameters and time frame.
• Designand conduct experiments to identify process issues related to undesirablereagent or manufacturing performance, and identify resolutions for thoseissues.
• Plan,conduct, analyze, and document experiments necessary to improve manufacturingprocess capability and reduce costs associated with paper-based reagentproduction.
• Leadcross-functional manufacturing support team and mentor junior biochemists.
• Providetechnical support for OEM product/process investigations and improvements;customer complaint investigations; and customer service support information requests.
• Lead root-causeinvestigations and drive implementation of those solutions to improve reagent performanceand manufacturability.
• Able todesign complex experiments, execute test protocols, and analyze/interpret theirresults.
• Applyprincipals of lean manufacturing and support continuous improvement activitiesto meet quality, cost and supply requirements.
• Effectivelycommunicate (oral and written) work progress in both intra- andinter-departmental team forums.
• Providewell-written, coherent progress updates, validation documents, study protocols,and technical reports.
• Participatein supplier and internal audits; able to interact effectively with keysuppliers.
Qualifications:
• PreferredBachelors or Masters in Biochemistry or Chemistry.
• 3-5 years' experience, preferably in a medical device or related industry
• Strengthin one or more of the following areas: Clinical Chemistry, Immunoassays, AnalyticalChemistry, Biostatistics, Manufacturing Process Capability, and ComputerScience.
• Provenexperience in successful root cause analysis and resolution of manufacturing ordesign issues.
• Demonstratedcompetence in experimental design and data interpretation
• Workingknowledge of basic statistics necessary to develop sampling plans and analyzedata.
• Able toprepare technical reports and testing protocols per approved department andsite procedures.
• Must bewell versed in Office Applications, particularly Excel and Access; experiencein SAS, or Minitab desired.
• Sometravel (< 10%) may be required.
Othercharacteristics of the successful candidate:
• Veryorganized, detail-oriented
• Highlyself-motivated
• Able towork independently
• Excellentanalytical, communication, writing, and problem-solving skills
• Effectiveand influential in his/her interactions in team-based assignments
• Able towork well with personnel from different departments, and experience levels
• LeanManufacturing and CAPA Investigator experience
• Demonstratesgood laboratory and manufacturing practices
• Workingknowledge of manufacturing process performance trending
AtSiemens Healthineers, we value those who dedicate their energy and passion to agreater cause. Our people make us unique as an employer in the med-techindustry. What unites and motivates our global team is the inspiration of ourcommon purpose: To innovate forhealthcare, building on our remarkable legacy of pioneering ideas thattranslate into even better healthcare products and services. We recognize thattaking ownership of our work allows both us and the company to grow. We offeryou a flexible and dynamic environment and the space to move beyond yourcomfort zone to grow both personally and professionally.
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Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Full / Part time: Full-time
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