Job Posting Structure Now’s our time to inspire the future of healthcare together. Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us. Join our team now at Siemens Healthineers Lab Diagnostics as a Staff Systems Integration Engineer (Assay Integration and Performance) in the R&D Systems Engineering organization. The Systems Engineering organization is the technical hub for integrating the chemistries, mechanics, fluidics, robotics, electronics, and control systems to develop and launch new products for lab and molecular diagnostics. This role is open at Tarrytown, NY or Glasgow, DE. There may be travel up to 15% domestically and internationally. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Staff Systems Integration Engineer (Assay Integration and Performance), you will be responsible for leading the assay and instrument integration activities in new product development and installed fleet support for laboratory diagnostics product lines. The position reports to the Head of Systems Assay Integration and Verification within the Systems Engineering organization. Responsibilities of Senior Staff Systems Integration Engineer (Assay Integration and Performance): • Be a leading team member to a group of engineers and scientists from diverse fields to drive the development of Laboratory Diagnostics products from concept, design characterization, system and assay integration, verification, design transfer and through commercialization. • Work closely with product definition, design engineering, scientists (chemists / biochemists) to define the requirements for next generation diagnostics products (clinical chemistry and/or immunoassay systems) • Develop into the Assay Integration Subject Matter Expert (SME) to support new product development and installed fleet for lab diagnostics product lines as well as serve as the single point of contact with the R&D Assay development organizations • Lead the design and integration of reagents/assays with laboratory diagnostic products that will meet the defined product/customer requirements • Conduct frequent and early confidence building testing to provide feedback/guidance and influence the design process • Direct and execute the verification/integration for each diagnostic product • Develop into a key resource to support the validation of the diagnostic products • Participate in the design transfer to manufacturing by providing SME support to manufacturing engineering for test method development and manufacturing validation activities • Write plans, protocols and reports that are compliant with 21 CFR 820 and ISO 13485 • Oversee, plan, and execute experiments to study design feasibility, and identify & characterize critical design parameters and their boundaries that influence assay performance • Identify solutions (hardware and software) to complex technical issues by troubleshooting, determine root cause, and then propose design modifications as they pertain to system & assay performance • Provide systems technical guidance and knowledge transfer to internal fleet support and service teams when instrument/assay performance issues arise at critical customer sites. • Analyze system & assay performance test data and establish acceptance criteria • Write & review data-driven technical summaries and test reports • Ensure compliance to all quality procedures and policies of product development. Oversees procedures pertaining to: o System integration o Engineering prototype configuration management during system verification o Technical and Product Risk Management o Design transfer to manufacturing o Manufacturing /Quality Control Systems support o Reliability FMEA and performance metrics • Collaborate with all Design and Commercial Product Engineering teams as well as Assay Development, Project Management, Marketing, and Sales This position may suit you best if you are familiar with what is below, and would like to develop your career with Healthineers Desired skills for success in this role: • Prior Laboratory and molecular commercial product experience, i.e., Versant, Roche, Abbott, Thermo Fisher, BD, Illumina, Pacific, Oxford, Agilent, Qiagen, Cepheid, etc. • Experience handling samples like blood, purified DNA, bacterial pellets, fresh and tissue material • Experience implementing and troubleshooting IVD assays on a high throughput platform • Experience integrating other instruments (e.g. plate readers, sealers, barcode readers, mixers/shakers) with a high throughput platform like the Hamilton STAR or Agilent BRAVO • Ability to use scripting or coding languages to control laboratory equipment • Familiarity with the capabilities and challenges involved in an automated pipetting system • Experience with Design of Experiments and Statistics analysis • Experience in the development of at least one product that has successfully completed most of the product development phases i.e., Concept and Feasibility, Design, Verification, Validation, Design Transfer, Product Launch, Product Support • Knowledge of FDA and international quality system regulations and processes. • Understanding of the electro-mechanical, software, mathematical, chemical, or biochemical process operations in diagnostic systems • Knowledge of Systems Engineering best practices • Six Sigma DFSS training • Experience with Agile/Scrum Required skills for the success in this role • PhD in Chemistry/Biophysics/Biochemistry/Biomedical Engineering with 7+ years Medical Devices industry experience in new product development and installed fleet products. • Demonstrated experience with laboratory diagnostics assays and lab practices • Demonstrated understanding of the steps involved in a laboratory IVD assay -- sample acquisition, sample prep, detection, readout • Work experience as part of large integrated, cross-organizational multi-disciplinary teams. • Strong verbal and written communication skills • Learning mindset and clear thinker 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 COVID-19 vaccination for all new hires by their start date except where prohibited by state law. (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. 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. Organization: Siemens Healthineers Company: Siemens Healthcare Diagnostics Inc. Experience Level: Experienced Professional Job Type: 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. Pay Transparency Non-Discrimination Provision Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here. California Privacy Notice California residents have the right to receive additional notices about their personal information. To learn more, click here.