Job ID: JOB-11847
(4-8 months travel in Puerto Rico to set up a new line, before returning to Galway)
This position offers a great opportunity for a Mechanical Engineer to work in a dynamic and challenging environment. This role will support Client customers in the Healthtech (Medical Device) market so we are inviting candidates that have experience in Automated / Pharmaceutical or Medical Devices in particular. The Mechanical Engineer will be part of the site engineering team providing process, technical solutions for new / upgrading projects on existing systems and equipment. This will involve interacting with the site operations, EHS, maintenance, utilities, technical and quality teams ensuring that the proposed solutions are acceptable. Engineering services include Process Development, Process Validation, tool and fixture design, and capacity expansion. The candidate for this role needs to display knowledge of clean automated manufacturing and Pack operations, have strong process validation and project management experience, to deliver engineering actions on time and within budget. This role will report to the Engineering Manager.
- Executes the functional deliverables associated with the New Product Development, Project Management, and Quality Systems.
- Design and specification of equipment and systems to current regulations and design standards.
- Writing, conducting, analysing, determining and reporting on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.
- Support validation assessment and validation execution for Clean, Automated and Packaging processes
- Assist in SAT/FAT as required.
- Applies technical knowledge to innovate, design, and develop processes, procedures, fixturing and/or automation.
- Prepares and presents technical data and recommendations at technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., Requirements, BOMs, Validation Plans and Reports, FMEAs, etc.)
- Writes validation protocols and reports applicable to new processes.
- Develops qualified production lines, while working with the Manufacturing Operations.
- Provides Design for Manufacturability (DFM) and Design for Test (DFT) input to the engineering print package.
- Complete process characterisation confirmations and OQ/PQ as required and associated plans and reports
- Establishing process methods which meet performance and quality requirements.
- Manage the maintenance and calibration of critical equipment-systems
- Competent working knowledge of automation.
- Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
- Literacy of engineering drawings for geometric dimensioning and tolerance.
- Competent to effectively communicate manufacturing plans, proposals, results and negotiate options at management levels.
- Excellent report writing, analytical and problem solving skills as well as understanding of root cause analysis methods.
- Skilled user of engineering tools and software packages to design and automate manufacturing processes .i.e. AutoCAD, SOLIDWORKS.
- Skilled in writing and execution of Validation protocols, IQ/OQ/PQ, FAT, SAT, CAPA, FMEA, SOP’s, Control Plans
- Familiar with control procedures, such as the Change Notification and Deviation process, and Engineering Specifications.
- Experience in reviewing mechanical drawings
- Familiar and knowledgeable in Clean, Packaging Operations and new product introductions.
- Ability to engage and communicate effectively with design disciplines.
- Strong attention to detail and possess excellent documentation and data analysis skills.
- Strong project management and organizational skills and the ability to maintain projects.
- Microsoft Office Suite and Project; Statistical Process Control skills;
- Methodical approach to problem solving
- Minimum 3+ years’ Process Automation experience.
- B.Sc. in Mechanical, Industrial or other Engineering Science, preferred Mechanical Engineering.
- Requirement for FDA/ISO13485 Medical Device experience.
- Handling project assignments of large scope and complexity and able to prioritize and complete work in a timely manner.
- Equipment and fixture design, along with test systems development experience.
- Process Development; equipment validations and process characterization experience.
- Travel requirements
- Extensive Travel requirements & project assignment which could last for up to 8 months in duration.
For further information on this role please contact Tommy McKeown on 086 0100903 / email@example.com
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