Ref No: AM17379
Co. Dublin, Ireland
Design / Solutions Engineer (Product Lifecycle Engineering) - North Dublin.
This is a permanent role within the Engineering team in the support of medical device equipment. The successful applicant will work within the Engineering team in providing comprehensive support to products in maintaining and updating the product design and associated processes. The role will require a high-paced self- starter who can deliver solutions to deadlines, working in a highly collaborative environment.
The individual will be part of a team, who will form the link between R&D, manufacturing, contract suppliers, customer support, marketing, and service. They will be involved in the day to day running of a product with the ability to lead problem-solving activities with suppliers and manufacturing involving electromechanical / fluidic systems. This will include the design and verification of technical solutions to solve problems, enhance products and process capability in the areas of electromechanical, automation, materials, software & fluidics.
A background in modern medical device instrumentation such as Haematology, Biochemistry, Immunoassay, chemistry, fluidics, pneumatics, electro-mechanics, software, databases, electronics, optics, statistics, etc. either as a designer or applications specialist would be an advantage.
You will form part of a flexible engineering team covering Manufacturing Engineering, Product Lifecycle Engineering and Customer Complaints. You should have the ability to work cross-functionally in a complex environment and be able to lead and drive cross-functional teams.
Key aspects of the role:
1) To provide design solutions to technical problems within the products & processes to enhance product reliability, reduce costs and solve customer facing problems.
2) Provide technical & process support on the manufacturing of medical device product platforms in a high complexity and highly regulated technology environment.
3) Work closely with manufacturing, marketing, and customer service in driving solutions to meet customer needs.
4) To investigate customer complaints and drive solution development with a cross-functional team.
5) Report on product health by performing Data Analysis on parts usage, complaints, field service visits and other KPI’s, and reporting findings to management.
6) Driving projects & tasks to meet business needs at pace using Agile Scrum, always with a clear customer focus.
7) A deep technical competency in the area of electrical / electronic / mechanical / automation design is required with a proven ability to design or redesign solutions.
8) Troubleshooting capability required to analyse problems to root cause with a structured approach and fully develop solutions, including all associated planning and design verification and validation activities. Statistic / Data analytic background would be an advantage.
9) You will require an ability to work across a significant subset of the key technologies involved such as fluidics, moulding, electro-mechanics, software, electronics, optics, machining, metal fabrication etc.
10) You will be considered a local process owner, and be able to develop and manage systems of metrics for manufacturing and projects. Complete systems analysis and develop projects to drive continuous improvement in key metrics in alignment with Lean, 6 Sigma, Design Robustness Principles and A3 Problem Solving Principles. You may be a member of several project teams working with Manufacturing Engineering, Product, Q.A., R&D, Service and Continuous Improvement.
11) You will participate in the continuous development of the quality system, including standard operating procedures (SOP's), workflow development, product and process validations coupled with the ability to write concise technical reports.
Interested applicants should have:
Bachelor’s degree in Engineering (biomedical, systems, mechatronic , electronics, mechanical, engineering or similar) with a minimum of 5 years' engineering experience in a related role.
This role requires an individual with a strong aptitude for systems level thinking, experience as a Field or Applications specialist would be an advantage.
High-paced strong engineering background with a proven record in problem solving and the design / redesign of equipment.
Understanding of regulatory requirements required (IEC, IVD, Machinery Directive etc.)
Excellent communications skills (written and verbal) are required to be able to work with a cross-functional team.
Experience working in a highly regulated environment would be an advantage in either service support or R&D of medical equipment.