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Position Summary:
Principal Software Program Manager provides strategic leadership for the planning, execution, and delivery of complex software development programs within the medical device space that are critical to business success. This senior leadership role oversees a portfolio of software initiatives, manages and mentors Program Managers, and partners with executive leadership to align technology...
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Position Summary
The HR Generalist is responsible for providing support in one or more functional HR areas, including but not limited to recruiting, employee relations, business partnering, benefits/leave of absence, process and program administration, and training. This role carries out administrative work involving the human resources function and maintains related records; supports policy implementation, HR programs, and procedures to improve the effectiveness of HR.
The annual base salary range for this role is...
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Job Summary
The Facilities Leader plays a critical role in ensuring the Transfusion sites remain safe, compliant, reliable and fully operational, enabling employees and core business activities to function effectively and without disruption. This role is accountable for leading a team of Facilities and Maintenance professionals dedicated to maintaining facilities, grounds, equipment, and environmental health and safety for diagnostic manufacturing, distribution, and business functions as well as supporting the ongoing success and strategy for the Transfusion business. This leader is responsible for all aspects of facility operations,...
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Position Summary:
The Senior Manufacturing Test Engineer is responsible for designing, developing, and validating
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Job Summary
The Associate Field Service Specialist builds and maintains relationships with customers to retain North American customer install base while performing thorough installations, repairs, preventative maintenance, and product enhancement activities on highly complex Werfen instrumentation and systems. Responsible to meet Service Delivery Key Performance Indicators while maintaining costs and achieving service revenue targets.
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Job Summary
The Field Service Engineer builds and maintains relationships with customers to retain North American customer install base while performing thorough installations, repairs, preventative maintenance, and product enhancement activities on highly complex Werfen instrumentation and systems. Responsible to meet Service Delivery Key Performance Indicators while maintaining costs and achieving service revenue targets.
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Position Summary:
The Staff Systems Verification Engineer partners with cross-functional product development teams to support the integration, verification, and testing of In Vitro Diagnostic (IVD) products. This role provides technical mentorship and guidance to Verification Engineers while ensuring product quality and alignment with market needs. The role includes driving the architectural design, deployment, and practical use of robust test automation frameworks to verify regulated medical device software and hardware. Additional responsibilities include developing and maintaining design verification...
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Position Summary:
Responsible for facilitating, coordinating and processing change orders. This person may be responsible for drawing work, including Pro E and Auto CAD, Windchill interface. Determines how to improve and maintain the change control system and associated processes by means of lean and operational excellence activities. Acts as the primary interface between engineering, manufacturing, field service, marketing, etc. to ensure the appropriate changes are properly documented and implemented. Manages the quality manual system document facilitation...
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Job Summary
The Intellectual Property (IP) Counsel is responsible for providing high quality IP service to the entire Werfen organization. The position reports directly to the Chief IP Counsel.
The IP counsel is responsible for strategically establishing patent portfolios in different business areas, perform freedom-to-operate, assist with IP due diligence, support internal clients and manage outside counsel, and work closely with both the business and the Chief IP Counsel on a daily basis.
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Job Summary:
The QC Lab Technologist I is responsible for the execution of a broad range of bench test procedures used in the QC testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory. The QC Lab Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards.
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Position Summary:
Plans and controls inventory of finished goods for warehouses/distribution centers and manufacturing plants to meet sales and distribution demand. Analyzes inventory levels, planned production, and sales forecasts. Develops/maintains inputs to computerized inventory management system.
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Job Summary
Performs various tasks and duties to ensure the appropriate day-to-day support for the operations of the Vialing, Labeling, Packaging, and Solid Phase Departments.
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We are looking for a Material Handler to join our shipping/warehouse manufacturing team. This position is responsible for the tasks and functions involving shipping, receiving, storing and distributing materials, parts, supplies, and equipment in our Norcross warehouse facility.
If you have the necessary qualifications for this position, we want to hear from you. Apply today!
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Job Summary
The Senior Staff Software Engineer is a senior technical leader and individual contributor responsible for the architecture, design, implementation, and delivery of complex software for medical and connected device products. The engineer operates across real-time embedded systems, device connectivity and management, application software, and system interfaces; translates ambiguous product and system needs into robust technical solutions; and influences decisions across functions and projects. The Senior Staff Software Engineer remains technically hands-on while mentoring engineers, raising engineering standards, and helping teams make...
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Position Summary:
Join a collaborative and highly visible R&D team where you will play a key role in advancing diagnostic assay development through verification and validation. As a Research Associate III, you'll take ownership of complex development projects, contribute to design control and process improvement activities, and serve as a technical resource for both your team and cross-functional partners. This is an opportunity for an experienced research associate who enjoys working independently while collaborating closely with colleagues across R&D, Manufacturing, Quality, and Operations.
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Job Summary:
Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key...
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Position Summary:
The Senior Engineering Group Lead will have a player-coach technical authority for Class II and Class III coagulation programs — you will own design controls, product reliability, and a five-person systems engineering team.
This role will assign and oversee the practical application of technology across multiple programs, leading requirements management, risk management, verification and validation, and traceability from...
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Position Summary:
Using company procedures, quality system requirements, and engineering best practices, performs process development, characterization, and validation activities in support of new product introduction (NPI) and platform-based initiatives. Independently plans and executes process characterization studies, process optimization efforts, and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Analyzes process data to identify trends, assess process capability, and...
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Job Summary
The Calibration & Facility Technician III is responsible for a variety of tasks involving: managing the preventative maintenance and calibration, and on-demand repair program[SS1.1] [SS2.1][KS2.2]for all manufacturing and laboratory equipment ensuring timely resolution and compliance with Werfen’s procedures and exoectations. Provide oversight and support to the Manufacturing and Quality Control laboratory equipment. Other miscellaneous tasks to help keep facility up and running for optimal manufacturing operations.