New Product Introduction Engineer
Location: Carrick-on-Shannon, Co. Leitrim, Ireland
We are currently hiring a Medical Device – New Product Introduction Engineer:
- Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
- Strong interpersonal and communications skills.
- Ability to manage multiple tasks and adapt in a challenging, fast paced environment.
- 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 lay-out, production procedures, material specifications, material & packaging procurement in accordance with the company’s Procedures and Regulatory standards.
- 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 team work, 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.
- Engineering qualification in Polymer, Medical, Mechanical, Design or equivalent.
- Minimum 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.
- Fully PC literate.
- Highly competent in catheter manufacturing processes, including extrusion, moulding, balloon forming, braiding, packaging and other assembly techniques.
For further information contact Sean on 094 90 29944.