Siemens Biochemist, Sr Staff in Newark, Delaware

Biochemist, Sr Staff

Locations:Newark, Delaware

Job Family: Research & Development

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Job Description

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%

Division Description:


Job Description:

SENIOR STAFF BIOCHEMIST (System/ Assay Integration and Characterization)

Position Overview:

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

Risk Analysis

  • 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

  • Agile/SCRUM training

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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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