Manager, Hand-held Assay Integration, Verification & Validation 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 Manager, Hand-held Assay Integration, Verification & Validation to support new product development efforts and on-market products related to the hand-held blood gas product line. 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 Manager, Hand-held Assay Integration, Verification & Validation, you will be responsible for leading assay integration efforts to drive development decisions on new products and consumables or to support design change activities for on-market products. You will also be responsible for the verification and validation activities throughout the product lifecycle management process, including stability and shelf life of consumables & new products; verification & validation of new and existing products; and regulatory submittal support activities for in vitro diagnostics (IVD) instruments and consumables of the hand-held product line. Key Responsibilities: Manage a cross-functional team of R&D Professionals to support the hand-held blood gas road map Develop team capabilities and capacity through coaching, training, and stretch assignments Set mutual performance expectations with direct reports, monitor progress, recognize accomplishments, and support their development and project deliverables Collaborate with peers in new product development to optimize processes and tools Ability to multi-task and to support multiple project teams Manage validation of new and revised assays and/or platforms. Cultivate, maintain, and strengthen cross-functional relationships and networks within R&D, Manufacturing, Quality, Marketing and Service to achieve business targets Support, drive timely closure for all escalated assay-related field complaints and manufacturing issues Collaborate with Product Owners to regularly review resource needs and review team deliverables Required education/experience, skills, and qualifications: BS in a Science or Engineering discipline with a minimum of 5 years of experience working in multi-disciplinary, cross-functional teams with project leadership and/or product lifecycle management responsibilities. Experience in sensing technologies is preferred. Strong fundamental scientific background 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 Experience in facets of clinical science including professional technical writing for protocols and reports, including statistical analyses Strong quantitative skills and demonstrated application of complex experimental and statistical methods Skilled in systems thinking Comfortable operating in a fast-paced, multi-functional organization with competing priorities Experience with use of Agile methodologies Must be a self-starter with strong analytical decision-making and multi-tasking capabilities to support multiple project teams Experience with coordinating R&D teams to develop, execute and complete assignments for new and existing Point of Care products 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. 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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