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Sr. Mfg Eng; Process Quality, Hardware Engineering Services - Manufacturing
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Staff Quality Systems Engineer
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We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This…

Werfen

Team Manager, Integration Engineering

Norcross, GA, United States

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Job details

Apply by: Nov 4, 2027
Experience: Minimum of 10 years of related work experience
Posting language: English
Posted: Nov 4, 2024

Original job 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

Responsible for hands-on technical and team leadership of Integration Engineers across assay, reagent, software, hardware, instrumentation, and system verifcation activities. The role will help to define integration approaches, resolve complex system issues, and ensure technically rigorous verification evidence for automated and manual testing systems.

Responsibilities

Key Accountabilities

Technical and Team Leadership

Lead Integration Engineers through technical planning and execution of system integration engineering and verification activities across assay, reagent, software, hardware, and in-strumentation interfaces.
Expands team depth through mentoring, shared methods, knowledge transfer, and perfor-mance management.
Build Integration Engineer team capability in systems thinking, design controls, verification strategy, scientific and statistical methods, technical writing, traceability, risk management, and investigation practices.
Provide focused people leadership of Integration Engineers necessary to support technical execution, including assignment of work based on competency, removal of technical barri-ers, timely feedback, and development planning.

Design Verification & Validation

Apply requirements-based, risk-based, and evidence-driven approaches to verification planning, execution, analysis, and reporting.
Assess integration and verification readiness by evaluating requirements testability, equip-ment and method readiness, dependencies, technical risks, and availability of qualified re-sources.
Review and approve V&V deliverables by evaluating assumptions, methods, acceptance criteria, analyses, traceability, and conclusions for scientific and engineering rigor.

Regulatory & Compliance

Integrate design control, documentation, traceability, and procedural requirements into technical execution.
Collaborate with regulatory affairs to ensure compliance with relevant industry standards and regulations.

Problem-Solving and Risk Assessments

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, experi-mental evidence, structured problem solving, and cross-functional expertise.
Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Works in cross-functional relationships with team members of Quality, Regulatory, Marketing, Operations, and other R&D functions.
Coordination of project deliverables with Systems Integration Management, PMO, and the other cross functional teams is required to meet milestones.

Qualifications

Minimum Knowledge & Experience required for the position:

Master's Degree (MA); or equivalent combination of education and experience
Minimum of 10 years of related work experience
Science or Engineering Degree (Biomedical Engineering preferred)
Advanced knowledge of the design control process for medical devices (IVD preferred)

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

Strong verbal and written communication skills specifically related to complex biological concepts and technical documentation.
Effective collaborator across departments and with cross-functional teams.
Demonstrates ability to priortize and manage multiple workloads efficiently in a fast-paced environment.
Intermediate proficiency in Microsoft Office (Word, Excel) and specialized systems (TrackWise, MasterControl, SharePoint).
Receptive to feedback and direction; works cooperatively with managers and peers.
Proven ability to work independently and as part of a team.
Organized and detail-oriented with strong problem-solving skills.
Committed to continuous improvement and operational excellence.
Maintain records and files of work and revisions according to procedures and processes by following cGDP.

Travel requirements:Minimal – less than 5%.

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

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More about this job

Skills

Team leadership
ICT system integration
Coaching
Systems thinking
Technical writing
Risk management
Leadership
Reporting
Regulatory compliance
Documentation
Regulatory affairs
Problem solving
Troubleshooting
Root cause analysis
Biomedical engineering
Medical devices
Communication skills
Microsoft Office
Microsoft Word
Microsoft Excel
MasterControl
Microsoft SharePoint
Work independently
Process improvement

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