Senior Systems Integration Specialist

3 weeks ago


Norcross, Georgia, United States Immucor Full time

We are seeking a highly skilled Principal Systems Integration Engineer to join our team at Werfen. The ideal candidate will have a Master's Degree and four to ten years of experience in IVD development, with a focus on software, systems, and assays.

The successful candidate will be responsible for leading and contributing to multiple projects, developing strategies for integration, and performing advanced troubleshooting on automated systems. They will also be responsible for maintaining adherence to PDP and GDP, and performing statistical and verification data analysis at an advanced level.

The Principal Systems Integration Engineer will be responsible for developing Verification Protocols, reviewing results, and writing summary reports. They will also anticipate the needs of the project and react accordingly, without direction.

The ideal candidate will have a strong background in science or engineering, and experience in IVD development. They will be a team player, with excellent communication and problem-solving skills.

Werfen is a growing, family-owned company with a strong commitment to innovation and customer satisfaction. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.

Responsibilities:

  • Identify testing plans for integration of new hardware components, assays, software, and products
  • Lead efforts developing strategies for assay, software, hardware integration
  • Lead team to evaluate/perform functional testing on new hardware/software versions created by the third party automation manufacturer
  • Evaluate/perform functional testing on new analyzers and/or new configurations to support product development activities and make decisions towards defining parameters
  • Design experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements.
  • Perform advanced troubleshooting on the automated systems
  • Maintains adherence to PDP and GDP
  • Perform statistical and verification data analysis at an advanced level
  • Develop Verification Protocols to assure Requirements and Specifications are fulfilled
  • Review results of executed Protocols and write summary reports and provide conclusions
  • Anticipate the needs of the project and react to them accordingly without direction
  • Perform traceability analysis of test protocol to Requirement
  • Maintain adherence to PDP and GDP
  • Write and execute moderately complex system related development and/or characterization protocols and data packages

Qualifications:

  • Master's Degree (MA); or equivalent combination of education and experience
  • Four to ten years of related work experience
  • Experience in IVD development (software/system/assay focus) required
  • Science or Engineering Degree, preferred

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V



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