|Job Title:||Process Engineer|
|Duration:||Fixed Term Contracts|
|Contact Name:||David Walsh|
We are currently recruiting for the position of Process Engineer on a fixed-term contract basis.
Functional Area: Engineering
Career Framework Title: Operations Engineering Specialist
Internal Job Title: Process Engineer
Job Level: 08
This position offers a great opportunity for a Process Engineer to work in a dynamic and challenging environment. You will be responsible for, and involved in, process development, troubleshooting, maintenance and continuous improvement of the production process and equipment in the manufacturing area. The successful candidate will work closely with the operations, technical and quality teams to drive projects to continually improve the line performance as well as solution and provide input to new business opportunities. This role could support a number of customers across the business in the Automated Technology Solutions & Healthtech (Medical Device) market so we are inviting candidates that have either Medical Device AND/OR Automation experience.
This role will report to the Engineering Manager.
- Monitors the performance of equipment, machines and tools, resolving equipment issues or improving process parameters that produce non-conforming products, low yields or product quality issues.
- Manages the maintenance and calibration of critical equipment-systems.
- Interfaces with cross-functional teams and external vendors to integrate new products, processes and technologies into the existing manufacturing area.
- Works alongside a project team of other manufacturing engineers to develop and execute reliable, cost-effective and high-quality manufacturing solutions for moderately-complex products from new product introduction through the end of the lifecycle.
- Supports and takes ownership of continuous improvement processes for production areas using the LEAN Six Sigma approach.
- Creates, executes, coordinates and contributes to the design of experiments, test methods, protocols, specifications and validation documentation (IQ/OQ/PQ) and supports the development and execution of qualification trials/characterisation studies
- Manages numerous projects, generates project plans and works with project teams to drive completion and success.
- Assists in the development of automated solutions for NPI programs including new business development opportunities.
- Supports the qualification of engineering change management.
- Experience using engineering tools and software packages to design and automate manufacturing processes.
- Experience creating CAPA, FMEA, SOP’s, Control Plans and performing validation (FAT, SAT, IQ, OQ, PQ).
- Using detailed analysis, modeling and methodologies to validate the manufacturing process and tooling design and specifications.
- Ability to effectively communicate manufacturing plans, proposals, and results, and negotiate options at management levels.
- Strong analytical and problem-solving skills.
- Excellent interpersonal & communication skills.
- Strong report writing & data analytical capabilities.
- Advantageous to have knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485, specifically in the areas of Change Control and Validation. Experience and Qualifications:
- Minimum 3-5 years’ experience in a Process Engineering role
- Primary Degree in an Engineering/Science discipline.
- Requirement for Medical Device AND/OR Automation experience.
- Experience in ISO13485 medical device manufacturing environment is desirable.
- Experience in a highly automated manufacturing environment is desirable.
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