Siemens Biochemist, Sr Staff in Newark, Delaware
Biochemist, Sr Staff
Job Family: Research & Development
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 231286
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 25%
SENIOR STAFF BIOCHEMIST (System/ Assay Integration and Characterization)
The System/Assay Integration & Characterization group is a System Engineering team focused on the development of automated medical devices for in vitro diagnostic (IVD). These medical devices provide rapid and accurate diagnostic testing for clinical laboratories 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.
The System/ Assay Integration & Characterization Engineering team has the responsibility of bridging Design Engineering to Assay Development. These specialized Systems Engineers/Biochemists drive the development, troubleshooting and transition of assays onto the IVD platform.
The Senior Staff Biochemist position is open at our Glasgow, DE site with travel (up to 25%) to our other two sites inTarrytown, NY and Flanders, New Jersey.
The position reports to the Head of Systems Engineering within the Design Engineering function of the Global Engineering Organization (GEO).
Responsibilities of Senior Staff Biochemist:
Assay Design Characterization & Feasibility
Key stakeholder and expert in developing design concepts to meet Assay performance requirements.
Lead Assay/Test Definition Design & Execution of experiments to study the feasibility & impact of various subsystem and system design options to identify & characterize critical design parameters and their boundaries on the assays.
Provide expertise and guidance in the development of test definition parameters.
Provide an in-depth understanding of all test definition parameters and how they impact assay performance
Participate and provide subject matter expertise in the safety risk analysis to assure the safety and efficacy of the assay interactions with the devices.
Lead technical/functional assay performance risk assessments to uncover and explore the design and project risks which could lead to the reporting of erroneous results.Problem Solving
Assist and take ownership in the Solution of complex technical issuesby troubleshooting, determining root cause, and then proposing design modifications as they impact assay performance.
Support assay development (GAD) during new instrument Assay Performance feasibility, integration, verification & validation by reviewing data, triaging failures, troubleshooting, determining root cause and providing issue resolution by working with entire GEO team.Integration & Verification Testing
Coordinate, oversee &plan protocols to effectively test designs against assay performance requirements and customer needs.
Direct a team and also write test plans and protocols to effectively test designs
Evaluate data and establish acceptance criteria
Review system & assay performance test data and compare to established acceptance criteria.
Write clear, data-driven, technical summaries and test reports.
Provide technical leadership and experienceCustomer Support
Provide Assay Integration support for product launches and continued customer usage.
Provide expertise and support in the operation of the system and system software, including research, service and customer modes.
Proficient with review of system software logs; including debug logs, instrument logs etc. used as tools for troubleshooting assay performance.
Lead small teams when necessary for complex and multi-functional issues
Required Knowledge/Skills, Education, and Experience:
B.S in Engineering or Biochemistry/Biological Sciences required
12+ years working experience as Biochemist/Systems Engineer in new product development
Significant work experience in 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 hardware/software platforms
Capable of providing direction and technical guidance to Product Engineers on the teamWork 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:
Experience with thermal control and/or robotics a plus
Six Sigma DFSS training a plus
Equal Employment Opportunity Statement
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