Senior Moulding Development Engineer
Process Development
Medical Device - Munster Region (Ireland) - Product Development
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Our client is a leading global leader in the Design, Development, Manufacture and Sale of Class III cardiovascular medical devices. Located in the Munster region the Irish facility is engaged in the Technical Transfer, Development and Manufacturer of technological complex devices and currently wishes to strengthen its in-house Development Team through the appointment of an experienced Polymer/Materials Engineer. The ideal candidate for this vacancy should have an all round background in the injection moulding sector including experience of Tooling Engineering, Coordinating 3rd party Design ( Mould Makers & Component), Process Optimisation ( Moulding & Ancillary Equipment, Robotics) & Polymer Materials, Validation ( IQ,OQ,PQ) and Testing Methods. Applicants should also posses excellent Communications and interpersonal skills along with prove Project/Programme management abilities. You should ideally hold a degree in engineering preferably in Polymer or Materials or have completed post graduate masters in Biomechanical or Polymer Engineering.
Responsibilities:
- Assess and quantifying test method capabilities and limitations which includes challenging laboratory equipment/instruments and test method procedures.
- Applies technical knowledge to innovate, design, and develop methods/processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the Product/Technology Development Process
(PDP/TDP), Project Management, and Quality Systems.
- Prepares and presents technical data and recommendations at technical reviews.
- Writes validation protocols and reports applicable to new processes.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s,
Routers, FMEA’s, etc.).
- Review existing Standard Operating Procedures (SOP), identify improvements and partner with
production, DA and/or R&D to modify/implement solutions in accordance with established document control procedures.
- Oversees development builds associated with the project using special work requests.
- Interact & follow-up on project status for test method development.
- Work with R&D and Production to implement improvements and to incorporate lessons learned
and/or feedback from previous projects as well as support next generation test methods.
- Participate in investigational studies, problem solving and root cause analysis.
- Contributes ideas to or generates Intellectual Property submissions.
- Trains and/or provides work direction to technicians and may train manufacturing personnel
when required as part of a validation.
- May serve as core team member or extended team member on new product projects.
Applicants will ideally hold a formal qualification in Plastics/Polymer/ Materials ( Post Graduate or Primary Degree) and have attained a BSc/BE degree in Biomedical, Pharmaceutical, Chemical or a related Engineering field preferred. Experience in analytical methods and/or process development of products (medical devices or related field) preferred. Demonstrated ability to prioritize multiple tasks/projects with a strong problem solving ability. Excellent interpersonal and communication skills with good leadership abilities
Research & Development Director
Medical Device
Our client is a Research & Development company engaged in the design and development of Invasive Class III Medical Device Products. We are looking for an experienced R&D Engineer with BE Degree in Engineering and minimum of 10+ years experience in the medical device industry preferably cardiovascular or endovascular. The ideal candidate must have experience in managing the development and release into the market of an "implantable, Class III medical device" from conception to commercialization. Applicants must have a desire to work autonomously with a small team, be able to do engineering tasks themselves as well as organize and direct a small team to develop a product that meets the the clinical design expectations whilst ensuring meeting time and on budget targets.The position reports to the Chief Executive Officer (CEO). Applicants must have excellent hand-on and technical team leadership including a deep understanding of design programmess/CAD and Solid Works/MS Project and be able to build detailed time/cost charts for project tracking a presentation.
Material Technician
Medical Device - Galway
Our client is a leading global Medical Device company with significant R&D and Manufacturing activities located at its subsidiary facilities located in Galway, Ireland.
Job Role: Part of core team to respond to equipment, material and process related issues.
Key Responsibilities:
- Work with Manufacturing Engineers in developing, trouble shooting, standardising and improving existing production methods and procedures.
- Assist ME’s in investigating material related issues.
- Assist ME’s in design methods, part sourcing and documentation.
- Perform equipment qualifications and validations, including report writing.
- Design, specify, manufacture, test and document production equipment, changes and improvements.
- Interface with a variety of Boston Scientific personnel and with outside vendors when necessary while
performing the above.
- Take responsibility for preventative maintenance procedures with an assigned process or area.
- Assists in implementing technical improvements under the teams Continuous Improvement program.
- Communicates any concerns about work process regarding environmental impact, health or safety issues
to their Manager.
- Build Quality into all aspects of work by maintaining compliance to all quality requirements
Skills, Experience & Qualifications:
Third level qualification, preferably a Certificate / Diploma in Polymer/Materials Engineering or equivalent.
General manufacturing processing knowledge with at least 2 years previous experience in a manufacturing environment with preferably medical product experience.
Good technical capabilities, communication skills, teamwork abilities and initiative.
Ability to work on own with minimum supervision
Working Conditions
The majority of the work will be spent on-site in a manufacturing / cleanroom environment
There may be a requirement as part of the role to travel to other sites.
Senior Injection Moulding Technician or Process Engineer
Location - Sligo - Ireland
Permanent Weekend Shift ( Friday or Monday + Saturday/Sunday )
Reporting to the Production Manager, the Moulding Technician is responsible for the installation, maintenance, troubleshooting, modification and continuous improvement of moulding processes and equipment.
Key Responsibilities
Key role in assisting the complete validation of new and existing equipment - including acceptance trials, debugging and validation of new equipment and tools Maintenance of moulding equipment at optimal performance levels in accordance with the highest engineering standards
Specific fine tuning of moulding equipment to improve and increase output
Reducing downtime and waste
Maintaining good housekeeping in the moulding area
Dealing/liasing with vendors, suppliers and local engineering shops
Analysis of customer complaints and internal quality issues and development of improvement programmes for equipment to eliminate these defects being produced
Assistance in the training of technicians/apprentices as required
Education:
Candidates should hold the National Craft Certificate and/or relevant 3rd level qualification preferably coupled with relevant further training courses and qualifications.
Work Experience:
Time served or Polymer experience.
Minimum of 5 years' industrial experience preferably in a regulated industry and experience of injection moulding.
The ability to apply a scientific approach to problem solving, blending analytical and experimental skills to maximise productivity and yields.
Excellent interpersonal and communication skills.
Computer literacy would be advantageous.
Supervisory experience is desirable
The ability to work as part of a team and on own initiative.
Quality Engineer(s)
Medical Device - Galway - Fixed Term Contract
Our client is a leading global Medical Device company with significant R&D and Manufacturing activities located at its subsidiary facilities located in Galway, Ireland
The position requires the successful applicants to act as the engineer for a technology or product line on site with responsibility for ensuring all quality standards and specifications are defined and achieved in line with Corporate and Regulatory requirements. Under broad supervision/guidance compiles and analyses operational test and experimental data to establish performance standards for newly implemented or modified products/processes and ongoing auditing of existing processes.
Key Responsibilities:
- Identifies and resolves complex exceptions to work assignments.
- Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Continually seeks to drive improvements in product and process quality.
- Acts as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA
- Director as the final arbitrator on critical quality decisions.
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
Skills, Experience and Qualifications:
- A graduate of Engineering, Sciences or equivalent (HETAC level 8),with a minimum of 3 years experience in a healthcare products environment.
- Is capable of giving technical guidance to Associate Quality Engineer, Technician and Inspection staff.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
- Should be able to deal with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
Quality Engineer
Medical Device - Galway - Permanent
Our client is a leading global Medical Device company with significant R&D and Manufacturing activities located at its subsidiary facilities located in Galway, Ireland
The position requires the successful applicants to act as the engineer for a technology or product line on site with responsibility for ensuring all quality standards and specifications are defined and achieved in line with Corporate and Regulatory requirements. Under broad supervision/guidance compiles and analyses operational test and experimental data to establish performance standards for newly implemented or modified products/processes and ongoing auditing of existing processes.
Key Responsibilities:
- Identifies and resolves complex exceptions to work assignments.
- Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
- Continually seeks to drive improvements in product and process quality.
- Acts as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
- Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
- Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
Skills, Experience and Qualifications
- A graduate of Engineering, Sciences or equivalent (HETAC level 8),with a minimum of 3 years experience in a healthcare products environment.
- Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
- Should be able to deal with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
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