MDR Product Engineer
Job Description Summary
BD, also known as Becton Dickinson, provides pen needles for the care of Diabetes patients globally. The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the BD organization, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across Operations, Engineering, Quality and R&D.
BD is looking for an enthusiastic and capable MDR Product Engineer who will provide support for the Diabetes Care Research and Development team located in their brand-new facility onsite at BD's Dun Laoghaire manufacturing facility. You will support the large-scale R&D workstream as part of the key strategic MDR remediation programme as well as lending support to the broader R&D team on a day to day basis. As part of an expanding and highly visible team you will have excellent opportunities to broaden your knowledge and develop your career within an exciting Global business. This is an 18-month Fixed-Term Contract role.
- Edit and prepare new/revised documents and forms that are submitted for the documentation control process, ensuring their compliance to ISO, GMP and FDA regulations;
- Be responsible for leading the engineering change request/order ECR/O documentation process;
- Prepare R&D test samples & perform hands-on mechanical product testing & other studies as required for the MDR programme R&D workstream. Document and report on findings;
- Maintain compliance to all applicable regulatory standards and current GMP procedures and practices;
- Organise/plan daily tasks to meet project timelines;
- Liaise with external vendors for laboratory equipment selection, installation / qualification;
- Have a proven ability to multitask and support multiple complex projects simultaneously;
- Contribute actively to R&D project planning;
- Identify and facilitate continuous improvement activities.
The successful candidate will have solid educational background with a degree in engineering, quality or relevant scientific discipline with 3 year’s relevant work experience or a diploma with at least 5 years relevant work experience.
The ideal candidate will have knowledge and understanding of Good Lab practices (GLP) and Quality Management Systems (QMS). You will have experience in an ISO accredited lab environment. Previous experience in a medical device testing laboratory preferred.
You will have the ability to work independently with minimal supervision as well as in a team environment. You should display excellent multi-tasking, analytical, communication and prioritisation skills. You will be an excellent communicator with ability to run meetings and workshops.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
BD’s benefits are very attractive including a bonus scheme with the option of either cash or BD Shares, Family Health Insurance, better than average pension contributions based on your full salary and other fantastic benefits.
You can look forward to a rewarding career, collaborative working and opportunities to expand your skills and progress your career in this fast moving, dynamic and agile business.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Then check out emea.jobs.bd.com
Primary Work LocationIRL Dun Laoghaire - Pottery Road
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Current Employee - Anonymous, Limerick