NPI Engineer
Job Detail
Location | Leitrim |
Salary | Negotiable |
Posted | |
Role Type | Permanent |
Contact | Tommy McKeown |
jobs@hero.ie |
NPI Engineer
NPI Engineer
Commutable from Sligo, Longford, Roscommon
Required Qualifications/Experience/Skills:
- Third level engineering qualification in Polymer, Biomedical, Mechanical, Design; Minimum Bachelor’s Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent)
- Ideally 2-3 years’ experience in new product introduction, manufacturing, quality or process engineering, preferably in catheter manufacturing.
- Experience in Project Management regarding new product introduction, preferably in a Medical Device environment.
- Preferably highly competent in manufacturing processes used for manufacturing catheters etc., including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.
Duties / Accountabilities (incl. Deputation): This involves but is not limited to:
- Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved.
- Planning, implementing and co-ordination of New Product Introductions to include: product design, product specifications, process validations identification of training needs, process & equipment layout, production procedures, material specifications, material & packaging procurement.
- Ensure the requirements of ISO 45001, ISO 14001 and ISO 50001 are considered during design, development and new product introduction and integrated into production processes.
- Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of new and existing production. Co-ordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements.
- Ensuring effective and comprehensive customer communication throughout the duration of the project.
- Planning and co-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality.
- Planning and co-ordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files.
- Development of Manufacturing Process in conjunction with New Product Introduction Team including, as required, training of technicians, process operators and other staff.
- Planning and implementing manufacturing cell lay-outs, work station design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.
- Leading Project management teams to ensure on-time task completion, effective teamwork, good motivation and effective communication.
- Especially in the area of New Products but also existing products, participation in areas such as Customer Complaints, CAPA’s, etc., either as responsible for timely closure or providing technical support.
- Completing any tasks within the project scope including validations, testing, product design and so forth.
- Supporting the business acquisition process by way of completing quotations for piece part prices, equipment and other project costs. Providing technical support and customer communication as required.
- Completing other tasks as assigned.
- Management of PAO/Trainer/Technician/Associate/NPI Engineers, as applicable (Senior NPI Engineer).
- Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
- Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
- Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc.).
- Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
For further information on this role please contact Tommy McKeown on 086 0100903 / jobs@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Tommy McKeown
JOB-11307
NPI Engineer
Tommy McKeown
Role Type | Permanent |
Contact | Tommy McKeown |
jobs@hero.ie | |
mobile | +353 86 010 09 03 |
linkedIn profile | click here |
![]() |
Senior Compliance Specialist
Sligo
Senior Compliance Specialist My client a leading pharmaceutical company in Sligo is looking to hire a Senior Compliance Specialist on…
MDR – MDR/Vigilance Specialist
Galway
Title MDR/Vigilance Specialist Duration: 12 months Location: Work from home / Ballybrit Galway Start Date: ASAP…
IT Business / Systems Analyst
Galway
Title IT Business/Systems Analyst Summary Our client, a medical device company in Galway is currently looking to recruit an…