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
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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