Project Engineer
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 Qualifaction 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.
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