Validation Engineer Medical Devices Jobs in Rochester, NY

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Description Summary:

Location: Onsite - Rochester, NY

The Logistics Coordinator II is responsible for coordinating, programming (if applicable), shipping and receiving of medical devices, imaging phantoms, site documentation, and all supplies/resupplies to support a global customer base within the clinical research industry. The Logistics Coordinator II will manage supply chain responsibilities in order to maintain sufficient levels of supplies and equipment to fulfill requests. This person will be responsible for using the inventory system to enter orders and report monthly metrics to management. This position requires global logistics knowledge, development of importation documentation to ensure seamless distribution internationally, and the ability to coordinate shipments through alternative courier providers when international countries do not accept the preferred vendor. This position is also responsible for processing the receipt of devices both from the vendor and from sites.

This position requires technical knowledge of cardiac equipment to configure devices per site specifications, troubleshoot/repair devices, to manage the RMA program and coordinate with equipment manufacturers when repairs

outside our capabilities are needed. They will monitor and address shipment alerts and notifications by coordinating remedial action through the courier service to ensure shipments reach their intended location on time.

Responsibilities:

• Creation, assembly and/or distribution of all supporting documentation for the shipments of medical devices, supplies, imaging phantoms or site documentation to a global customer base to support clinical research
• Develop all international documentation to meet the specific requirements of each country, clinical research organization, sponsor, and site
•     Manage all communications and activities with external logistical courier services, related to required documentation and timelines for delivery and pickup, and will ensure receipt by the depots and/or sites. This position will be the main point of contact for any issues with these shipments providing support to the external courier service, depot, or site
• Requires technical knowledge of cardiac equipment, including but not limited to, ECG, Holter, ABPM and TTM devices in order to support configuration, troubleshooting and minor repairing of devices.
• Responsible for managing the evaluation of all returned equipment, any repairs of returned equipment and the communication with Project Management regarding status of returned equipment via the RMA program
• Monitoring and assisting with any alerts of exceptions identified while the shipment is in transit and facilitating the resolution by liaising with the appropriate internal and/or external stakeholders
• Assisting and regularly communicating with management to monitor and maintain supply chain flows to ensure sufficient levels of supplies and equipment are available to satisfy business needs
• Liaise with Operations and/or the distribution center to ensure timely and quality shipments with proactive risk identification and mitigation strategies. This includes providing feedback to the distribution team when errors in shipping are identified, ensuring there is understanding of the root cause and will participate in creating and driving solutions to prevent future issues
• Responsible for all department training for Logistics Coordinators ensuring they understand job tasks, responsibilities and acting as the subject matter expert for the department and other departments in need of education or information
• Assist with Customer Support tasks as needed
• Ad hoc projects as assigned by management

What you need:

• Medical Device experience is a plus.
• Experience working in the shipping industry preferred
• Vendor management experience is preferred
• High School Diploma or BS Degree is a plus
• MS office experience: Excel and Power point

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Salary Range

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