TITLE: Senior System Engineer COMPANY: Siemens Healthcare Diagnostics, Inc. DUTIES: Responsible for demonstrating project leadership in next generation rapid testing solution development for Point of Care applications. Engage with the portfolio development teams and with Key Opinion Leaders (KOL) to help build a project proposal. Contribute to feasibility and development efforts throughout the complete product lifecycle: High-level design, concept research, breadboard and prototype evaluation, system integration testing, manufacturing launch and product sustaining. Define System and Subsystem Requirements, establish design documentation and specification for parts, assemblies, and/or finished products. Collaborate with several cross-functional teams to create concepts, explain system functions, system integration and lead features and clinical solutions to facilitate a successful product launch. Lead integration efforts by developing and executing integration plans across projects and features at both the system and subsystem levels and track the progress. Work with the System Verification Team on protocols to verify the requirements and create traceability matrices and work effectively throughout the project to drive efficiency improvements. Work with regulatory professionals to execute reports and evidence for product performance claims, intended use, safety to use and product risks as needed to clear FDA and IVDR regulations. Work in Agile teams and take leadership role in defining product backlog, prioritize backlogs, engage with stakeholders, and manage timely project deliverables. REQUIREMENTS: Master’s degree (or foreign degree equivalent) in Biological Sciences or Biomedical Engineering, or a related field, and 6 years of experience in the job offered or an acceptable alternate occupation. In the alternative, employer will accept a bachelor’s degree in the above listed fields and 8 years of experience in the job offered or an acceptable alternate occupation. Full term of experience must include the following skills: Extensive functional and technical knowledge in the areas of qualitative and quantitative immunoassays development; Broad knowledge in fast nucleic acid testing and sample collection methodologies; Strong understanding of lateral flow assays including microfluidic manipulations and optical detection systems; Experience in understanding customer requirements, designing and optimizing complex diagnostics systems under design control; and Proficient project management skills and experience in managing R&D projects. Must also have at least 1 year of experience with the following skills: project management experience working in an Agile environment; and Broad knowledge in blood gas analyzers and quantitative measurements in whole blood. Approximately 10% travel required. 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. (Note: Accommodations may be requested for certain medical or religious reasons). OTHER: Norwood, MA. 40 hours/week; $141,110/year. If offered employment must have legal right to work in U.S. EOE. CONTACT: Elizabeth Ewalt Siemens Healthcare Diagnostics, Inc. 2 Edgewater Drive Norwood, MA 02062 Please reference job code: EL/RM 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.