Overview:
We are looking for a Process Development Engineer with experience in medical device research and/or development roles to join our team. The ideal candidate is someone who can work independently, thrives under pressure and is committed to an exceptional level of delivery standards. You will join a newly established Life Sciences Practice in Expleo Ireland, working on key projects and helping to grow the team.

expleoIJ

Responsibilities:

• Provide support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle
• Set up new manufacturing equipment/production lines and assist with staff training, as required.
• Apply new technologies and methodologies to optimise process design & performance.
• Work with external vendors to specify, develop and commission new process technologies.
• Liaise with Business Development, R&D, Manufacturing & Quality to ensure that the transition of products through R&D product approval and manufacturing scale up are smooth, timely and cost effective.
• Design/source equipment and tooling required to meet both the capability & capacity requirements.
• Execution of process validation activities.
• Complete equipment validation including URS, FDS, FAT, EIQ, EOQ…
• Execute work plans & schedules for development activity

Qualifications:

• Degree Qualified in Engineering or Science related discipline

Essential skills:

• Excellent client-facing skills
• People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
• Team work and emotional intelligence
• Good self-management – continuous performance is both an objective and a mind-set
• Has an innovative approach – a bold thinker and doer, matching creativity with vigilance

Experience:

• 1-3 years Engineering experience in Medical Device industry or other regulated industry
• Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485 and FDA CFR 820). Knowledge of Stage-Gate process and/or Product Development life cycle.

Benefits:
At Expleo, we are committed to providing a competitive salary and a substantial benefits offering with unique wellbeing, financial and employee recognition programmes.
We pride ourselves on our diverse and inclusive culture and offer a variety of family friendly policies and enhanced leave to help our you achieve a healthy work life balance.

By providing significant learning and development opportunities, we encourage individual growth and success throughout your career with us.

• Collaborative working environment – we stand shoulder to shoulder with our clients and ours peers through good times and challenges
• We empower all passionate technology loving professionals by allowing them to expand their skills and take part in inspiring projects
• Expleo Academy - enables you to acquire and develop the right skills by delivering a suite of accredited training courses
• Competitive company benefits such as medical and dental insurance, pension, life assurance, employee wellbeing programme, sports and social events, birthday hampers and much more!
• Always working as one team, our people are not afraid to think big and question the status quo.

“We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age”.

Responsibilities:

• Provide support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle
• Set up new manufacturing equipment/production lines and assist with staff training, as required.
• Apply new technologies and methodologies to optimise process design & performance.
• Work with external vendors to specify, develop and commission new process technologies.
• Liaise with Business Development, R&D, Manufacturing & Quality to ensure that the transition of products through R&D product approval and manufacturing scale up are smooth, timely and cost effective.
• Design/source equipment and tooling required to meet both the capability & capacity requirements.
• Execution of process validation activities.
• Complete equipment validation including URS, FDS, FAT, EIQ, EOQ…
• Execute work plans & schedules for development activit