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.
Desired Skills and Experience
Project Engineer, Validation, FAT, SAT, IQ, OQ, PQ, Equipment Qualification, Cleanroom, Labelling, Packaging, Assembly