Overview
EPM Scientific are currently seeking a Project Engineer to join a Medical Device Manufacturer in Cork on an 18 month, full time hourly-rate contract. The role will be supporting the Qualification and Installation of new machinery, primarily in Labelling, Packaging, Assembly space, along with a new Cleanroom.
Responsibilities
* Designs, validates and brings new products to market.
* Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design\'s overall effectiveness, cost, reliability and safety.
* Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials.
* Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability.
* Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.
* Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the new product development procedures.
* Project manage the introduction of new capital equipment and support the associated qualification and validation activities.
* Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space ensuring optimum process flow.
* Ensure quality of process and product as defined in the appropriate operation and material specifications.
* Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.
* Support capital acquisition activities.
* Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
* Conduct MSA studies for new products and new processes.
Desired Skills and Experience
Project Engineer, Validation, FAT, SAT, IQ, OQ, PQ, Equipment Qualification, Cleanroom, Labelling, Packaging, Assembly
Seniority level
* Entry level
Employment type
* Full-time
Industries
* Medical Equipment Manufacturing
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