Design Engineer

CPL

Galway

Role Description. A medical device manufacturing company is looking for a Design Engineer in Galway. Reports to: Senior Engineer. Overview: Success is driven by the ability to work independently across multiple departments combined with a high degree of time management and organisational skills. Performance is measured upon competently fulfilling the core duties. Responsible for supporting the wider business as needed. Responsibilities: Manage small projects, both internally and on behalf of clients (e.g. project planning, quote/budget, tracking, risk management, reporting, communications etc.) Continuously monitor project performance against resources, timing, budget, risk and results and report variance to contract. Prepare reports/documentation to communicate status and results internally and to customers. Execute projects in accordance with ISO13485 / FDA 21 CFR 820.30 process. Compile full product specification packages for Production Release (component drawings, inspection criteria, material specs, work instructions, packaging specs etc.) As part of the design team, the candidate will be expected to work closely with, and manage both internal and external specialists to progress projects through to completion. Management of customer communications. Maintain Dept. Processes in line with Industry best practice. Ensure documentation/drawing standards for equipment meet company standards. Comply with internal and external regulatory requirements by ensuring that documentation such as Product development, manufacturing process and test specifications / procedures are completed and are in compliance. Develop products in Solidworks from inception through to transfer to production. Complete dimensional 2d Quality control drawings for manufacturing. Participate in the development of Design Verification Test protocols and reports. Complete process development activities such as tolerance development to ensure robust function and process capability. Complete Risk Management as per ISO requirements. Liaise with manufacturing function to ensure manufacturability of products. Complete form, fit, function assessment, tolerance and capability analysis on high cavitation moulded assemblies. Analyse data and problem solve using six sigma tools. Work within a multidisciplinary team on diverse projects. Manage prototyping activity within the project. Resolve design, testing and manufacturing issues as they arise. Participate in PR and Sales support activity as required. Criteria: 3 years minimum engineering experience in medical device or other highly regulated manufacturing environment. Relevant Mechanical or equivalent Engineering Qualification (2:1 Bachelor Degree minimum. Track record of external customer management. Highly proficient in Solidworks: building complex parts/assemblies and high level 2D dimensioned & toleranced drawings / product specifications. Capability in kinematic maths and engineering maths is essential. Capable of analysing designs via FEAs and simulations.Excellent analytical and creative problem solving skills. Must have an excellent understanding of design for manufacturing of injection tools and assembly processes. Experience in design and development of plastic products for manufacture and assembly and of manufacturing processes, e.g. Injection Moulding, Extrusion, Bonding etc. Fluent in design/development processes and tools (six sigma training & minitab proficiency an advantage. Proficiency in administrative software: MS Word, Excel & PowerPoint. Excellent communication and presentation skills (written, verbal and visuals). Ability to efficiently report visually on design ideas/development is essential. Experience in compiling full product specification packages for Production Release (component drawings, inspection criteria, material specs, work instructions, packaging specs etc.) Personal Qualities: Results driven and able to deliver. Demonstrates a strong commitment to achieving results in collaboration with key internal and external customers. Excellent oral communication and presentation skills (written, verbal and visuals) for all levels of the organisation and customer base. Commercially aware, able to develop effective project, and operational plans. Ability to deal with and manage change. Demonstrate flexibility and ability to adapt to changing requirements. High energy with the adaptability and flexibility to deal with continuous change and innovation. A strong strategic orientation with good day-to-day tactical management and attention to detail. Effectively handle multiple priorities. Interested candidates please contact Rebecca Meaney on +35391507509 or email rebecca.meaney@cpl.ie. This job originally appeared on RecruitIreland.com.

2496 days ago