Principal System Integration Engineer - Transfusion at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

0.0

Posted On

08 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

System Integration, Design Verification, Design Validation, Hardware Testing, Software Testing, Reagent Evaluation, DOE Methodology, Statistical Analysis, Troubleshooting, Verification Protocols, Traceability Analysis, Risk Management, FMEA, IVD Development, Data Analysis, Protocol Review

Industry

Herstellung medizinischer Geräte

Description

Introduction 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. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary 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. 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/reagent 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 Represent the Verification team on project core teams 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. Review and approve verfication and validation protocols and reports, as assigned Manage execution of verification and validation protocols Review technical risks and take appropriate action May assist in developing SHA and FMEA for Risk Management Support moderately complex investigations of system issues Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel Additional task assigned as needed to support ongoing integration projects related to product, assay, software and hardware Networking/Key Relationships Works closely with Systems Engineering, Quality, Regulatory, Assay Development, and occasionally Marketing and Clinical teams. 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 Skills & Capabilities: Excellent written and verbal communication skills. Excellent analysis, troubleshooting, and debugging skills. Ability to perform in a fast-paced, agile environment. Ability to operate independently and exercise good judgment Understanding of technical content and the ability to communicate well with subject matter expert Works well with others in a collaborative, goal-driven environment Travel Requirements: N/A Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

This role involves proactively leading complex projects and design changes related to development, verification, and validation of products, assays, software, and hardware. Key accountabilities include identifying testing plans, leading integration strategies, performing functional testing, and designing experiments using DOE methodology.