Sr SYSTEMS ENGINEER in New Product Development
The Systems Engineering organization is focused on the development of automated medical devices for in vitro diagnostic (IVD) working with infectious diseases, oncology, cardiac markers, fertility testing, thyroid function, clinical chemistries and other clinical applications. From an engineering standpoint these medical devices rely on precision mechatronics, robotics, fluid delivery systems and thermal controls to allow for the accurate and precise reporting of patient assay results.
As part of the Siemens Healthineers Lab Diagnostics Systems Engineering team, the SR Systems Engineer will be responsible for the integration, design space characterization, and verification of systems for all new lab diagnostic development projects with a focus on assay performance.
The SR Systems Engineer position is open at our Flanders, NJ site. There may be travel up to 25% domestically and internationally.
The position reports to the Director of Systems Engineering within the Design Engineering function of the Global Engineering Organization (GEO).
Responsibilities of SR Systems Engineer:
· Work closely with cross-functional design team members to ensure that the full understanding of subsystem/system functionality and performance is developed
· Drive the development of systems design concepts to meet clinical chemistry and immunoassay performance requirements
· Develop expertise in the interaction between different elements of detailed design, give unique insight to the potential for emergent behavior and weigh merits of various design concepts against each other
· Oversee, plan and execute experiments to study design feasibility and identify & characterize critical design parameters and their boundaries
· Identify solutions to complex technical issues by troubleshooting, determining root cause, and then proposing design modifications as they pertain to lab diagnostic device system & assay performance
· Provide systems instrument technical guidance and knowledge transfer to internal fleet support /Services teams when escalated instrument analyzer issues arise at critical customer sites.
· Analyze system & assay performance test data and establish acceptance criteria
· Anticipate potential problems that may impact system performance and develop risk mitigation plans
· Write & review data-driven technical summaries and test reports
· Assure compliance to all design characterization, integration and verification quality procedures and policies of product development
· Oversees procedures pertaining to:
o Subsystem and system design characterization
o System integration
o Engineering prototype configuration management during system verification
o Design verification and traceability
o Technical and Product Risk Management
o Design transfer to manufacturing
o Manufacturing /Quality Control Systems support
· Collaborate with all Design and Commercial Product Engineering teams
Systems Engineering best practices
Required Knowledge/Skills, Education, and Experience:
B.S in Engineering or Biological Sciences required
· 5+ years working experience as Engineer in new product development and /or fleet system instrument support.
· Appreciation for the FDA regulated medical device industry
· Skilled in systems thinking with a broad range of knowledge and experience in systems requirements, integration, verification and validation
Strong grasp of engineering fundamentals and how to apply across
Work experience as part of large integrated, cross-functional teams.
· Strong verbal and written communication skills
· Learning mindset and clear thinker
Desired Knowledge/Skills, Education, and Experience:
· Work experience in the medical device industry
· Experience with CAD modelling and Mechanical Design would be a plus
· Experience with fluidics, robotics, and / or thermal control would be a plus
· Experience with Agile/Scrum
· Six Sigma DFSS training
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Early Professional
Job Type: Full-time
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