Job Description:

Role: Project Manager

Industry: Medical Devices and Healthcare Technology (HealthTech) industries

Employment Type: Fixed Term Contract (1 Year)

Location: Ireland

Notice Period: Immediate joiner required only

Where you come in:

• You collaborate and bring program leadership to highly complex cross-functional Ops Programs from inception through commercialization to include:
• Operations focused on commercial readiness for the Athenry Facility.
• New and improved manufacturing equipment/moulds/automation qualification, implementation, and transfer into internal and external manufacturing facilities.
• Production scale-up of products/processes.
• Change Order Plan (COP) closure and if needed support FDA filing
• You collaborate and drive process improvement activities that involve complex equipment or facility changes or additions with manufacturing.
• You establish strategies, advise, and communicate project/program plan and status to management and cross-functional teams.
• You anticipate and prevent issues with schedule, resources, and scope. You drive risk assessment as well as resolution.
• You partner with functional leaders and team members to drive Ops critical path program activities/ resources/ costs across all departments including:
• Technical team (Mechanical, Process, Electrical, Software, and Automation Engineering), Manufacturing, Contract Manufacturing, Procurement, Master Planning, Logistics/Distribution, Facilities, EH&S and others (Regulatory Affairs, Ops Quality, Finance, IT, etc.) within the boundaries of an indirect reporting structure
• You have the ability and confidence to run projects and provide updates as well as other key meetings.
• You are responsible for compliance with medical device regulatory standards for all aspects of the program.
• You work directly with suppliers and corporate partners, as appropriate.

What makes you successful:

• Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience.
• You have knowledge and work experience in Engineering, Automation, and Manufacturing.
• You demonstrate successful management of technical projects and programs.
• You have excellent communication skills with the ability to convey technical and business information clearly and effectively through informal and formal documents, reports, and presentations to senior management.
• You bring technical leadership experience and an understanding of regulated change control, product development process and medical device design control manufacturing transfer.
• You have technical knowledge and an understanding of FDA/ISO regulations working with GMP’s and ISO standards.
• You are proficient in Microsoft PowerPoint, Microsoft Excel, and project management tools (Smartsheet).
• Ideally, you have Program Management certification, i.e. PMP or equivalent.