The Manager, Training & Documentation for Manufacturing Support is responsible for leading the training and documentation team, focusing on the development, implementation, and oversight of comprehensive digital learning programs. This role enhances employee skills, drives organizational performance, and supports the company's digital transformation initiatives in drug substance manufacturing. The Manager, Training & Documentation designs strategic digital training solutions, develops accurate and user-friendly documentation, assesses training effectiveness, and fosters a culture of continuous learning and innovation.

The Director at Fujifilm Biotechnologies Texas (FLBT) plays a crucial role under the guidance of the Vice President of Engineering and will provide technical and process ownership for all aspects of clinical and commercial parenteral drug product manufacturing operations. Leadership and subject matter expertise is required in new technology introduction, equipment selection/qualification, technology transfer, process validation, scale-up, process monitoring, troubleshooting and continuous improvement. Collaboration with local and global departments is vital for overall success.

Territory Manager - Michigan West - Remote

As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment.  This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools. 

This position requires previous capital medical equipment sales experience.

To best serve the territory, prefer candidates currently located in the Michigan West area

The Automation Engineer 1, Building Management System (BMS) provides support to the entire facility ensuring efficiency and reliability of the automated systems that monitor and control environmental conditions and utility production. This role supports senior engineers with the implementation of changes to the automation systems, execution of testing and troubleshooting events, and provides on-call support, as needed. Initially, this role supports the expansion project for the facility with the scope evolving as the project progresses. 

Summary:  Under general supervision, the Logistics Specialist I is responsible for the accurate packing, shipping, and external distribution of cGMP (current Good Manufacturing Practices) and non-GMP materials in support of company operations.

The Manufacturing Lead (Downstream) oversees and performs Current Good Manufacturing Practice (CGMP) manufacturing operations for manufactured biopharmaceutical products. This role ensures the effective use of material, equipment, and personnel while making products at high-quality levels. Additionally, this role is recognized as a subject matter lead regarding manufacturing processes and leads more junior members of the shift through manufacturing processes.

The Executive Assistant acts as an executive support partner to leaders and their direct reports. The role involves coordinating site level projects, scheduling meetings, and managing calendars for leaders. This role anticipates upcoming needs of executives in a fast paced, growing environment.

The Regional Facilities Manager is responsible for the management of operations services within a Fujifilm USA facility including the building operation, maintenance and repairs, housekeeping, space planning, mail services, dock coordination and office equipment as well as budget and cost control oversight to ensure employee satisfaction and productivity. This position is responsible for the integration of telecommunication, security, safety, ISO 14001, vendor, and contractor management programs. This position is responsible for a regional Fujifilm facility as well as supporting other regional Fujifilm affiliate facilities.

The Manufacturing Lead (Upstream) oversees and performs Current Good Manufacturing Practice (CGMP) manufacturing operations for manufactured biopharmaceutical products. This role ensures the effective use of material, equipment, and personnel while making products at high-quality levels. Additionally, this role is recognized as a subject matter lead regarding manufacturing processes and leads more junior members of the shift through manufacturing processes.

The Leader, Hardware Engineering is a critical leadership position within the Fujifilm Sonosite R&D organization.  You will lead the Electrical Engineering, Mechanical Engineering and Transducer Engineering teams. The design covers ultrasound medical devices and associated peripherals. Your responsibilities include the timely design and deliverable of the products and accessories, the creation of models and prototypes.  As well as the generation of evidence required by 21 CFR 820 indicating that your teams follow design controls, and associated tests.  The leader will drive the teams to adopt reliability practices as well as six-sigma design practices including Dfx. As the Leader of Hardware Engineering, you will inspire and motivate your team to achieve new and exciting innovations and ensure Fujifilm Sonosite remains a top innovator in the industry. 

The Senior Project Manager is responsible for leading and executing strategic projects within the site, ensuring alignment with organizational goals and regulatory standards. This role involves managing multiple projects from inception to completion, optimizing project delivery, and fostering cross-functional collaboration to achieve business objectives.

We are seeking a Quality Assurance Coordinator who will be responsible for leading material inspections and partnering with cross functional groups to achieve the resolution of quality issues within the business. The Quality Assurance Coordinator will lead Receiving and Inspection activities to ensure that inbound material meets all mechanical, electrical and cosmetic specifications as identified in the quality inspection plan. They will support Supplier Quality Engineering with investigations associated with the Nonconformance Report process and the Materials Review Board.  They will also champion activities within Materials Management, Documentation Management, to meet and report related metrics.

The Clinical Consultant, MI – I shall be responsible for providing clinical consulting for the project, report configuration (CV), workflow analysis, end-to-end testing, remote or onsite training as well as go-live support to Synapse PACS/MI projects. In addition, provide clinical support for sales and company team members with respect to the use of the company’s products and serve as a consultant on behalf of customers and company personnel in compliance with the company’s quality procedures. Assist with TAC Support.

The FUJIFILM Integrated Inkjet Solution (FIIS) North American Sales Manager role is responsible for print system and consumable (fluids, spares, service, etc.) sales and sales growth for FIIS in North America. The successful candidate will be able to manage and develop existing accounts, as well as identify new leads and convert such leads into successful sales in the short, medium, and long term. Key targets for this role include driving growth of adapted print engine solutions onto analog presses in the commercial imprinting and packaging market segments. In addition, this role may require periodic interface with other FUJIFILM sales divisions for driving sales of standard FIIS products through these sales channels.

The role will include direct engagement with the markets and customers of interest through trade association presentations, trade shows, and direct customer lead generation and contact.  The role will require an initial assessment of opportunities to qualify leads, identifying technical success potential, size of the opportunities and fit with current and near-term capabilities. Continuous customer interaction can be expected in order to identify new opportunities, help solve problems as well as promote FIIS and understand – and improve - customer satisfaction.

The position will work independently and as a part of a team focused on driving new business opportunities.  Team members may include marketing, European sales, technical support, and business development people from other Fujifilm divisions in addition to those from Fujifilm Dimatix.

Excellent communication, presentation and interpersonal skills are needed. A reasonable analytical mindset is important, and the right candidate must be a disciplined self-starter that can act independently with minimum supervision. The role will require ability to travel - 50% travel occasionally on short notice, with greater travel amount needed periodically.

The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration for new products.   As a Regulatory Affairs Associate you will also work with Regulatory team members & international teams to drive systems & process improvement activities for integrated regulatory compliance and global submission processes, including labelling, clinical affairs, new product development, international regulatory requirements and other areas as assigned. 

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. 

As a Clinical Engineer, you will use your ultrasound expertise and skills to identify, document, design, and develop point-of-care ultrasound systems, imaging, and features. You will use your knowledge, curiosity, and industry best practices to ensure Fujifilm Sonosite products are clinically diagnostic, safe, and meet user needs as you actively participate in a range of research and development activities. You will conduct extensive research and gather key data points to define clinical workflows, guide requirements and designs, and inform current and future product development.

Being a Clinical Engineer at Fujifilm Sonosite means that you are an instrumental part of a passionate cross-functional development team that demonstrates FFSS core values. We are dedicated to creating reliable, durable, and easy to use point-of-care ultrasound systems that provide meaningful solutions to our customers.       

*** Hybrid Role ***