Principal Systems Integration Engineer

Overview:

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

We are seeking a Principal System Integration Engineer to join our team.

The Principal Systems Integration Engineer proactively leads and contributes to multiple moderate to complex projects and design changes in support of development and investigations. Responsible for developmental activities as well as design verification and validation related to products, assays, software and hardware

 If you’ve got the necessary qualifications for this position, we want to hear from you. Apply today!

This position is

not eligible for sponsorship for work authorization

Principal System Integration Engineer - Research and Development - Medical Device 

Responsibilities:

Key Accountabilities:

• 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

Principal System Integration Engineer - Research and Development - Medical Device

Qualifications:

Minimum Knowledge & Experience required for the position:

• 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

Principal Systems Integration Engineer - Research and Development - Medical Device

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

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

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