FUJIFILM Healthcare Americas Corporation is a leading innovator in diagnostic and enterprise imaging solutions designed to meet the evolving needs of healthcare across prevention, diagnosis, and treatment. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, magnetic resonance imaging, ultrasound, endoscopy, and endosurgery. The Synapse® Enterprise Imaging portfolio provides healthcare professionals with the imaging and data access needed to deliver a complete patient record. REiLI®, Fujifilm’s artificial intelligence initiative, combines Fujifilm’s rich image -processing heritage with cutting-edge AI innovations to inspire a new tier of clinical confidence. The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information please visit healthcaresolutions-us.fujifilm.com.

Job Purpose

This position is intended to lead and oversee HCUS Project Management.  This position is intended to successfully drive HCUS business projects that lead to continuous business improvement.

Duties and Responsibilities

• Supports HCUS leadership in strategic organizational planning (i.e., business case, financial analysis, requirements gathering) to ensure alignment with organizational goals.
• Supports cross-functional communication, collaboration, and alignment within the organization and with internal and external business partners.
• Directs and coordinates all aspects of organizational changes & initiatives (i.e., integrations, acquisitions, process improvements).
• Develops, establishes, and directs organizational project management operations.
• Establishes standards, governance, processes, and tools for effective project delivery.
• Establishes methodologies and metrics to evaluate results for all projects.
• Identifies and manages intra- and inter-project dependencies with other projects and organizational initiatives.
• Incorporates effective change and risk management controls.
• Maintains accurate project and capacity plans and up-to-date project assets and metrics.
• Develops and reports regular project performance updates and escalates business critical issues to senior management.
• Performs post-mortem analysis and lessons learned.
• Supports a positive and collaborative environment with a focus on communication and relationship building across the organization.
• Oversee and manage the HCUS Project Management staff to ensure continuous effectiveness.
• Manages and develops effective, collaborative project teams.
• Works collaboratively across departments and diverse personalities.
• Participates in all HCUS Management Review Meetings.
• Other duties as assigned.
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards.

Qualifications

• Certified Project Management Professional (PMP).
• Certified Six Sigma Black Belt (CSSBB).
• Master’s in Business Administration (MBA) highly preferred.
• Five (5) or more years of experience leading project teams in a highly regulated environment highly preferred.
• Proficient in Microsoft Project and other web-based project management tools.
• Working knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806 and 21 CFR 807) and international standard requirements (ISO 13485/ISO9001, ISO 14971, IEC 62304 and the Medical Device Directive) highly preferred.
• Excellent leadership, communication, collaboration, teamwork, and interpersonal skills.
• Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
• Excellent computer and internet search skills.
• Strong ability to multi-task and to meet business deadlines.
• Excellent organizational skills with an ability to think proactively, prioritize work and multi-task.
• Ability to work independently on numerous projects while meeting deadlines.
• Advanced written and verbal communication skills.
• Thrives in a constantly changing environment.

Physical Requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• The ability to sit up 75-100% of applicable work time.
• The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
• The ability to stand, talk, and hear for 75% of applicable work time.
• The ability to lift and carry up to ten pounds up to 20% of applicable work time.
• Close Vision: The ability to see clearly at twenty inches or less.

TRAVEL

• Occasional (up to 25%) travel may be required based on business need.

FUJIFILM is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.

If COVID-19 vaccine is mandated by the federal government, or by state or local government, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.