Team Manager, Integration Engineering

Werfen • Norcross, GA

2d

About The Position

Werfen is a growing, family-owned diagnostics company founded in Barcelona, Spain, in 1966. It operates directly in 30 countries and in more than 100 territories through distributors, with more than 7,000 employees. The company specializes in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant, and also researches, develops, and manufactures customized assays and biomaterials through its OEM business line.

The Team Manager, Integration Engineering provides hands-on technical and team leadership for Integration Engineers working across assay, reagent, software, hardware, instrumentation, and system verification activities. The role defines integration approaches, resolves complex system issues, and ensures technically rigorous verification evidence for automated and manual testing systems. It leads technical planning and execution, develops team capability, reviews and approves verification and validation deliverables, integrates design-control and regulatory requirements into technical work, and coordinates with cross-functional partners to support project milestones. Travel is minimal, at less than 5%.

Requirements

• Master's degree (MA), or equivalent combination of education and experience; management may substitute relevant work experience for a degree and/or make exceptions to the years-of-experience requirement.
• Minimum of 10 years of related work experience.
• Science or engineering degree; Biomedical Engineering is preferred.
• Advanced knowledge of the design control process for medical devices; IVD experience is preferred.
• Strong verbal and written communication skills, particularly for complex biological concepts and technical documentation.
• Ability to collaborate effectively across departments and with cross-functional teams.
• Ability to prioritize and manage multiple workloads efficiently in a fast-paced environment.
• Intermediate proficiency in Microsoft Office, including Word and Excel, and specialized systems such as TrackWise, MasterControl, and SharePoint.
• Receptive to feedback and direction and able to work cooperatively with managers and peers.
• Ability to work independently and as part of a team.
• Organized and detail-oriented, with strong problem-solving skills.
• Commitment to continuous improvement and operational excellence.
• Ability to maintain records and files of work and revisions according to procedures and processes by following cGDP.

Nice To Haves

• Biomedical Engineering degree.
• IVD experience with the design control process for medical devices.

Responsibilities

• Lead Integration Engineers in technical planning and execution of system integration engineering and verification across assay, reagent, software, hardware, and instrumentation interfaces.
• Expand team capability through mentoring, shared methods, knowledge transfer, and performance management.
• Develop team capability in systems thinking, design controls, verification strategy, scientific and statistical methods, technical writing, traceability, risk management, and investigation practices.
• Assign work based on competency, remove technical barriers, provide timely feedback, and support development planning.
• Apply requirements-based, risk-based, and evidence-driven approaches to verification planning, execution, analysis, and reporting.
• Assess integration and verification readiness, including requirements testability, equipment and method readiness, dependencies, technical risks, and qualified resource availability.
• Review and approve V&V deliverables for scientific and engineering rigor, including assumptions, methods, acceptance criteria, analyses, traceability, and conclusions.
• Integrate design control, documentation, traceability, and procedural requirements into technical execution.
• Collaborate with Regulatory Affairs to support compliance with relevant industry standards and regulations.
• Use data, experimentation, structured investigation, and cross-functional expertise to resolve complex system and product behavior.
• Identify technical issues and ensure timely evaluation, escalation, and resolution based on product risk and project impact.
• Facilitate advanced troubleshooting and root-cause analysis using system data, experimental evidence, structured problem solving, and cross-functional expertise.
• Coordinate project deliverables with Systems Integration Management, PMO, and other cross-functional teams to meet milestones.
• Maintain work and revision records and files according to procedures and processes by following cGDP.
• Perform other duties and responsibilities as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager