Job Overview:
This company has an opportunity for a Manufacturing NPI (New Product Introduction) engineer to support the operations team as we ramp through pilot production to commercial launch.
Responsibilities:
* Responsible for the execution of equipment, process and test method validations.
* Support the manufacturing process, understand the process risks and identify mitigations
leading to improving yields and process efficiency.
* Responsible for tracking and executing of New Product Introduction activities ahead of product commercialisation.
* Work with equipment vendors to identify areas for process improvement.
* Create a strong culture of problem solving using standard tools like DMAIC and 6 sigma.
* Create and follow a process development plan ensuring budget, risk and timeline have a high level of focus placed on them.
* Work closely with the R&D team to ensure their programs are also facilitated in the production plans.
* Work with R&D on materials, process and equipment improvement projects.
* Create and update existing master validation plan for the line equipment.
* Responsible for all line equipment, ensuring maintenance and calibration is up to date.
* Execution of IQ/OQs for lab and production equipment.
* Communicate and update project activities using project management methodologies.
Background & Qualifications:
* Bachelors in Mechanical Engineering, Manufacturing, Chemical Engineeering, Biomedical
Engineering or other relevant engineering discipline.
* At least 2 years work experience in a manufacturing or process development related role in a medical device company.
* Experience with new equipment introduction (IQ/OQ) and process characterisation and
validation.
* Experience with process characterisation and process validation, including test method
validation,
* Experience with processes like Lyophilisation.
* Demonstrated experience with GDP & GMP standards.
* Have an excellent knowledge of engineering materials used in medical device manufacture
such as hydrogels, metals and polymers.
A strong problem solver with knowledge and experience of DMAIC or other problem-solving
tools.
* Must be organised, demonstrate innovation, and have a strong work ethic on individual projects and as part of a project team.
* Effective communication skills. Both verbal and written - English.
* Extremely comfortable with hands-on and technical work.
Desired Skills and Experience
Manufacturing, NPI, Mechanical Engineering, Biomedical Engineering, Process Development, IQ/OQ, Lyophilisation, Validation and testing, Chemical Engineering,
Adecco Ireland is acting as an Employment Agency in relation to this vacancy.