Head, Assay Development and Integration 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. 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 Head, Assay Development and Integration to support development of next generation diagnostic assays and product lifecycle management activities for existing medical diagnostic products. This position is part of the R&D Franchise leadership team and reports to the R&D Franchise Head. 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. As a Head, Assay Development and Integration, you will responsible for leading a team of scientists and engineers tasked with the research, development and sustaining engineering activities for existing and next generation medical diagnostic assay products. Key Responsibilities: · Managing and developing a team of engineers and scientists in multiple locations worldwide supporting the Critical Care Franchises’ development initiatives · Serving as a member of the R&D Franchise leadership team and contribute to the overall Franchise strategy with a strong focus on quality and delivery · Initiates, directs and executes scientific efforts related to in vitro diagnostic assays and the associated analytical method validations for both next generation and on-market portfolio products. · Lead the establishment of product specifications through application of appropriate statistical tools and scientific rationale · Partnering very closely with the reagents/consumables development and systems development teams ensuring successful integration of all parts of the system to deliver a working solution for our customers. · Partnering very closely with the SCM teams and contract manufacturing partners to ensure smooth and effective design transfer · Ensuring all scientific work is done at the highest level of quality and all applicable practices and standards are applied · Coordinating across functions to resolve project impediments · Collaborates with key stakeholders to ensure efficient delivery (on time and within budget) of product development milestones, on market support activities and development investigations. · Keep current with advances in assay methodologies, including strategies to aid regulatory filings or expand core technologies. · Collaborate with external contract partners, as required, to support assay development, verification/validation, and improvement activities throughout the product lifecycle management process. · Apply analytical problem-solving skills to reagent and system integration issues to identify critical performance factors for assay development or improvement initiatives supporting on-market products. Cultivate, maintain, and strengthen cross-functional relationships and networks within R&D, Manufacturing, Quality, Marketing and Service to achieve business targets Required education/experience, skills, and qualifications: BS in a Science or Engineering discipline with 10+ years of experience working in multi-disciplinary, cross-functional teams with project leadership and/or product lifecycle management responsibilities. Advanced degree and experience in sensing technologies is strongly preferred. Strong fundamental scientific background rooted in the medical device or IVD space. Proficient in CLSI, ISO and other international guidelines for IVD manufacturers Experience in a regulated industry required to ensure alignment with regulatory expectations (FDA, IVDR) Knowledge of, and adherence to, Good Laboratory Practices, Quality Management System directives Comfortable operating in a fast-paced, multi-functional organization with competing priorities Experience with use of Agile methodologies and using Agile performance metrics to drive accountability and continuous improvement. Strong analytical decision-making and multi-tasking capabilities to support multiple project teams Experience coordinating and managing R&D teams to develop, execute and complete assignments for new and existing Point of Care products 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. 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. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law Applicants and employees are protected under Federal law from discrimination. To learn more, Click here. 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