Our client, a med device company in Cork are currently looking to recruit a Project Engineer for their site on a contract basis.
Technical role in in the New Product Development group. Collaborating with local and global functions including R&D, Engineering and Operations, the position will be responsible for developing, implementing and validating materials related processes for New Product Introductions ensuring optimum process capability and design for manufacturability.
The role involves working with a cross functional team to develop advanced manufacturing processes for the implementation of Coatings technologies and innovative processes delivering highly stable and effective manufacturing processes.
- Ownership for projects in New Product Development with a focus on coatings processes.
- Conduct detailed product / process design reviews.
- Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes.
- Implement design for manufacturability in new processes to minimise lifecycle cost.
- Deliver stable manufacturing process in line with stability metrics process.
- Implement cost effective material-related manufacturing solutions to drive engineering efficiencies.
- Perform materials characterisation and technical reports on materials analysis activities.
- Apply appropriate statistical and validation techniques based on overall risk.
- Validation of new processes.
- Provide timely and accurate reporting on project activities.
- Conduct feasibility studies to assess new technologies or process improvements.
- Project management responsibility for Coatings Development projects.
- Support root cause analysis activities related to coating processes.
- Ensure all activities comply with GMP, ISO and quality system requirements.
- Ensure that all health, safety and environmental requirements are fulfilled.
Education & Experience Requirements:
- BSc/BEng in Mechanical/Manufacturing/Biomedical Engineering (May consider BSc in Materials Science if the candidate has relevant Engineering Experience).
- Minimum of two years in product / process development, ideally in Class II / III medical devices.
- Strong interpersonal and team skills with ability to collaborate effectively and demonstrate conflict resolution.
- Solid planning and organization skills including attention to detail, multi-tasking, critical thinking and problem-solving skills.
- Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex.
- Flexible work ethic.
- Materials characterisation – advanced analytical techniques
- Proficiency of GD&T and ASME Y14.5M 1994 standards
- Statistical and problem solving engineering expertise (Six Sigma, SE or A3)
- Surface Science Characterization Expertise (XRD, SEM, EDX etc)
- Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements.
For further information on this Project Engineer Contract role in Cork please contact Anne-Marie Fox 087 2197421 / firstname.lastname@example.org
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