Senior Assay Development Engineer Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Our Point of Care Diagnostics Research & Development department is expanding its business and is looking for new talents to set up a new R&D dependance at our production site in Mishawaka, IN, US. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Senior Assay Development Engineer to work together with our multidisciplinary teams developing point-of-care medical diagnostics solutions. As Assay Development team we are developing and optimizing assays for disposable cartridges for use in our handheld blood analysis device that enables near patient blood testing in the acute care setting. Assays are being developed within the Research and Development department and the first assay has recently been transferred to our production site. In the role of Senior Assay Development Engineer in Mishawaka you will closely collaborate with our R&D site in Eindhoven, the Netherlands. This collaboration will involve regular visits to the Eindhoven site. Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers. Key Responsibilities: Serve as a liaison between the Research and Development and the Quality Control and Manufacturing organizations in Mishawaka. Ensure effective communication across functions on a global basis. Active support of transfer of new Assays from R&D to manufacturing. Support design change activities for on-market products. Acquire in-depth knowledge of our assays on disposable cartridges and related intermediate products. Apply analytical problem-solving skills to reagent and system integration issues to identify critical performance factors for assay development. Collaborate with key stakeholders to ensure efficient delivery (on time and within budget) of product development milestones. Support on market activities and development investigations. Partnering with external partners to support assay development, verification/validation, and improvement activities throughout the product lifecycle management process. Initiate and coordinate continuous improvement programs to optimize efficiency and minimize variation. Report progress and deviations to Program manager and Head of Assay Development. Required Education, Experience & Skills MS or PhD in Biochemistry, Biophysical/Technology Engineering or equivalent. At least 7, preferably 10+ years of experience in Assay development, preferably in In-Vitro Diagnostics or Medical Device industry. Experience with Product Creation and Quality Processes in a regulated industry required to ensure alignment with regulatory expectations (FDA, IVDR). Self-motivated and disciplined to get the job done. Ability to communicate clearly and concisely in written and spoken form. Team-player with excellent communication and technical skills in multi-disciplinary environments. Willing for regular intercontinental travel. Pro-active attitude with a can-do mentality. Demonstrated experience in complex experimental and statistical methods. Proficient in Microsoft Word, Excel, PowerPoint and familiar with statistical tools such as Minitab, Analyze-It or JMP. 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. Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site. If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers. If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about. As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. #LI-EM1 Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Full / Part time: Full-time Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. 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