Key Responsibilities
In this role, you will:
* Develop and refine manufacturing processes for new medical device projects.
* Manage multiple small to medium-scale projects, guiding them from concept through design for manufacture, commissioning, and qualification.
* Generate project proposals, plans, scopes of work, cost estimates, and quotations.
* Control the transfer of new product manufacturing processes to production.
* Liaise effectively with customer representatives, managing expectations regarding project progress, scope, and budget.
* Coordinate with various internal functional groups including EHS, QA, Manufacturing, Engineering, Supply Chain, Facilities/Maintenance, and Validation to ensure comprehensive project delivery.
* Track and report on project costs, schedules, targets, and achievements directly.
* Review and approve documentation, including specifications and drawings, and generate work instructions and action change notes.
* Manage internal and external teams to meet project schedules.
* Provide qualification and troubleshooting support for equipment and processes.
* Independently manage technical, engineering, and compliance matters, making decisions on engineering problems and methods.
What We're Looking For
We're seeking a candidate with:
* 3-5 years of relevant experience in project management or research & development, preferably within a medical devices environment. Similar regulated industries such as pharmaceuticals are also considered.
* Bachelor's Degree (Honors) in Engineering (Level 8).
* Proficiency in MS Excel and MS Project.
* Commissioning and Validation experience, particularly with equipment and processes.
* Strong oral and written communication skills (must be able to read, write, and understand English).
* The ability to work on your own initiative and meet challenging schedules.
* A highly organized, adaptable, and flexible approach to NPI/Project Engineering.
* Initiative, creativity, resourcefulness, and the ability to work independently.
Ideally, you’ll also have
* Proficiency in a CAD package such as SolidWorks, or equivalent.
* Experience working in a manufacturing environment that is ISO 13485 certified.
* Proficiency in an MRP package such as SAP.
This role operates within a normal manufacturing environment. The successful candidate will be expected to adhere to all safety regulations, maintain a clean and orderly work area, and wear appropriate Personal Protective Equipment (PPE) as required. Flexibility to support company needs is essential.
Location: Clonmel, County Tipperary, Ireland.
Seniority level: Associate
Employment type: Full-time
Job function: Engineering, Science, and Manufacturing
Industries: Medical Equipment Manufacturing, Manufacturing, and Pharmaceutical Manufacturing
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