We are looking for a Process Engineer with experience in medical device manufacturing and/or process development 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 highly motivated Life Sciences Practice in Expleo Ireland, consulting for our industry clients to provide expertise and practical experience and adding to the knowledge base of the Life Sciences Practice.
- Provide technical leadership and support to client project teams in process development, transfer, validations and compliance of products and processes
- Set up new manufacturing equipment/production lines or improve existing processes.
- Propose and implement state-of-the-art technologies and methodologies to optimise client processes & manufacturing performance.
- Work with clients and their vendors to specify, develop and commission new process technologies.
- Evaluate process and design alternatives for clients and drive a continuous improvement approach.
- Deploy lean and six sigma tools to identify and implement process and manufacturing improvements.
- Liaise with various functions on client sites to ensure that the transition of products through process development and manufacturing scale up are smooth, timely and cost effective.
- Manage projects in compliance with client procedures and in adherence to ISO and FDA regulations
- Development, execution and management of process validation activities.
- Complete equipment validation including URS, FDS, FAT, EIQ, EOQ.
- Understand and be involved with risk analysis for products and processes
- Generate work plans & schedules for development activity and execute to plan
- Degree Qualified in Engineering or Science related discipline
- 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
- Teamwork and emotional intelligence
- Good self-management
- Has an innovative approach
- High value on openness and transparency
- Strong interpersonal and communications skills, and fluent in English, both in writing and speaking .
- Minimum 5 years Engineering experience in Medical Device or other regulated industry
- Strong track record of project completion
- Knowledge of medical device quality & regulatory systems and medical device directive/medical device regulation
- 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 challenge 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”.
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