We are currently partnering with a Galway based medical device start-up who are looking to hire a Senior Manufacturing Projects Engineer as they expand. The Senior Manufacturing Project Engineer role offers unparalleled personal development opportunities within a strong positive cultural work environment.
This is a full-time role that carries with it an attractive package to include market leading salary, a benefits package including options for Pension and Healthcare. You will work in a supportive and collegiate environment that affords flexibility and a hybrid workplace.
Roles and Responsibilities
- Develop and maintain productive relationships with key partners in our manufacturing supply chain. Sourcing, interacting, and win-win management of external suppliers.
- Provide solid technical input and support to project teams in process development, transfer, validations, and subsequent commercialisation of products.
- Defines capacity and resource requirements to meet established project milestones.
- Co-ordination of New Product Introduction (NPI) in partner manufacturing sites.
- Development, execution, and management of process validation activities.
- Completing product, process and material changes through Process characterization, validation (IQ, OQ, PQ), change control and documentation updates.
- Support the writing and release of validation documentation; FMEA's, protocols, reports.
- Management of supply chain logistics to ensure sufficient supply to meet demand.
- Develops and implements programs in conjunction with Operations and Quality Functions, drive a continuous improvement, capacity, and cost in design for manufacture effectiveness.
- Manages projects in compliance with approved procedures in adherence to ISO and FDA.
Qualifications and Experience Required
- Engineering/Science degree or equivalent required (Master’s degree qualification preferred).
- 5 years + experience in new process introduction (NPI), within the medical device environment, Orthopaedics experience a plus.
For a more detailed job specification or a confidential discussion on this role contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091-706718