Senior Engineer required to join a Medical Device company based in Co. Galway.
You will be joining this company in an exciting growth phase and will have the chance to provide expertise and leadership.
You should apply if you have experience leading project teams, product transfers, in-depth knowledge of EU and FDA regulatory requirements and are looking for a diverse role with opportunities to progress.
A competitive salary, industry-leading benefits package and flexible working arrangments await you if successful.
Key duties & responsibilities:
- Act as the technical expert for process development, transfers, validations, and product commercialization.
- Manage a team of engineers and technicians including involvement in recruitment, CPD and mentoring.
- Direct NPI activities across plant collaborating with the senior management team to ensure best practice and process optimization.
- Management project teams working with R&D, Quality and Manufacturing across the product lifecycle and scale-up.
- Develops and implements programs in conjunction with Manufacturing Engineering, Operations and Quality Functions which drive a continuous improvement approach in the design for manufacture effectiveness
- Manages development projects in compliance with approved procedures and adherence to ISO and FDA regulations.
- Educated to degree or masters level, ideally in Mechanical, chemical, polymer, materials or biomedical engineering.
- Demonstrable Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
- Knowledge of the Stage-Gate process and/or Product Development life cycle
- Able to manage high-performance teams with proven experience in doing so.
- People management experience and further qualifications in project management.
Apply for this job now or get in touch with Michéal on 09064-90485.
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