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Werfen · 3 months ago

Principal System Integration Engineer - Transfusion and Transplant

US-GA-Norcross

Full-time

Onsite

Senior Level, Lead/Staff

4+ years exp

Werfen is a company focused on development and investigations in the medical technology field, and they are seeking a Principal Systems Integration Engineer. This role involves leading and contributing to complex projects, focusing on the integration of hardware, software, and assays, while ensuring compliance with verification and validation protocols.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

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/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 verification 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

Qualification

IVD developmentStatistical analysisTroubleshootingDesign verificationCommunication skillsAgile environmentJudgmentCollaboration

Required

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

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

Preferred

Science or Engineering Degree Preferred

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (10)

2024 (12)

2023 (10)

2022 (2)

2021 (11)

2020 (8)