Are you a Manufacturing Engineer with strong problem solving & validation skills? This could be the perfect role for you!
This company is a leader in medical devices spaces based in county Waterford!
- Designing manufacturing processes, procedures, and production layouts.
- Developing manufacturing processes and measurement systems.
- Developing relevant work instructions and SOP’s and provides guidance to operations on training.
- Providing guidance to operations regarding design concepts and specification requirements.
- Ensuring processes and procedures are in compliance with regulations.
- Delivering and managing projects within an agreed schedule.
- Working with internal and external customers and partners to deliver on projects.
- Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
- Writing and executing process and equipment validations (IQ/OQ/PQ).
Job Skills & Experience:
- 3rd Level Engineering Degree with a good hands-on working knowledge of medical device assembly.
- 4+ years of relevant experience in a highly regulated environment,
- Proven track record in the execution of protocols and validations to regulatory requirements.
- Successful track record of project managing validation activities and cost reduction projects.
- Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic)
- LEAN, Six Sigma experience
- Monitoring of materials, equipment and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
- Process background (development, capability, optimization, validation) within a regulated industry.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / firstname.lastname@example.org
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