Development Professional – Commercial Product Testing

Siemens Healthineers

2d•Hybrid

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Requirements

The position requires a Bachelor’s degree in Chemistry, Biological Engineering, or a related field and four (4) years of experience in the job offered or as a Chemist or a related occupation in the medical device industry.
Employer will accept a Master’s degree in Chemistry, Biological Engineering, or a related field and two (2) years of experience in the job offered, or as a Chemist, or a related occupation in the medical device industry.
The position requires two (2) years of experience with the following skills: Regulations governing the diagnostics industry, such as IVDR, ISO, FDA, or CFR; Analytical and reporting tools, such as Minitab, LIMS, or Microsoft Suite; Controlled Document Management tools, such as Teamcenter or SAP; Design of Experiments (DOE) and Failure Mode and Effects Analysis (FMEA); Installation and Qualification processes for medical devices, such as IQ, OP, PQ; Diagnostic platforms, including the Atellica CI (IM), Atellica IM, ADVIA Centaur CP/XP/XPT, ADVIA Chemistry 1800/2400/XPT, and the Versant kPCR Molecular.
Experience with the measurement principles and functioning of immunoassay/chemistry/molecular analyzers.

Responsibilities

Spearhead design change release activities for multiple Clinical Chemistry, Immunoassay, and Molecular Analyzers.
Evaluate the assay parameters and develop/build test definitions for Clinical Chemistry, Immunoassay and Molecular Analyzers.
Prepare engineering design changes.
Create and review plans for implementation and testing.
Create reports and documentation for test results.
Bring changes to the change review board for final approval.
Investigate potential product performance issues with multiple Clinical Chemistry, Immunoassay, and Molecular Analyzers.
Understand diagnostics reagents chemical properties and performance.
Design and execute studies for troubleshooting, issue investigation and mitigations.
Contribute to a wide variety of technical and cross-functional activities related to investigation of multiple Clinical Chemistry, Immunoassay and Molecular Analyzers.
Work closely with cross-functional team members to ensure full understanding of system/analyzer functionality and performance.