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Mechanical Engineer

  • Location: Galway, County Galway, Connaught, Ireland
  • Job Type:Permanent
  • Sector: Engineering
  • Contact: Rhys Joyce
  • Job Ref: 17463

My client, an exciting medical device company is looking to hire an experienced Mechanical Engineer to work in a dynamic and challenging environment. The role will involve extensive travel requirements which could last for up to 8 months.

Key Responsibilities:

  • 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 that meet performance and quality requirements.

  • Manage the maintenance and calibration of critical equipment systems.

Essential Knowledge/Skills/Competencies:

  • 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.

    Desired Experience/Qualifications:

  • Minimum 5-10 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 being 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 international Travel requirements & project assignments (Tech Transfer) which could last for up to 8 months in duration.

For a confidential discussion and more information on the role please contact Rhys Joyce.