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.
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.
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 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.
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.