Senior R&D Engineer
Location: Carrick-on-Shannon, Co. Leitrim, Ireland
We are currently hiring a Senior R & D Engineer:
- Self-motivated, thrives in a fast-paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
- Strong interpersonal and communications skills.
- Ability to manage multiple tasks and adapt in a challenging, fast paced environment.
- Generation of product & tooling drawings to support Quotations, Prototyping and Process Development.
- Product and process concept generation, presentation, prototyping and development.
- Providing technical support to the Sales and Marketing team.
- Creating assembly & project quotations and communicate effectively with customers.
- Dealing with customer enquiries and be able to communicate clearly both written and oral.
Product and Process Development
- Development of Products, Processes and Equipment, including product and material specifications, material sourcing, equipment and tooling specifications and sourcing, process development and testing, to develop new products for customers or the Company from concept to design freeze.
- Project manage all developments to ensure that all commitments are achieved including functional prototypes, delivery dates, design iteration samples, test protocols and reports, project costs and to ensure other project deliverables are achieved.
- Ensure full compliance with all Quality, Regulatory, Health and Safety and other relevant legislation. This will include the completion of Design History Files, Design Inputs, Outputs, Design Reviews, Log books, etc as necessary. Ensure full traceability of Design Development and control of changes.
- Ensure full and effective transfer of new products after Design Freeze to manufacturing areas ensuring that the product and processes are fully developed to allow product/process validation to begin. Provide comprehensive training to production, quality and technical staff to ensure a smooth production start including validations and records. Note that this stage is to be handled through the official change control (ECR/ECO) procedures.
- Constantly review development processes to ensure they are effective and compliant with the goal to achieve the optimum development cycles at minimum cost. Ensure Lean GROWTTH principles are followed especially 3P, 5S, DMAIC and 6 sigma.
- Provide effective internal and external reporting. Ensure Tax credit data and reports are maintained and compiled ongoing and are available at the end of each year.
- Ensure the R&D centre is fully equipped and maintained in excellent order. Motivate the development team and ensure effective use of resources.
- Train and develop associate engineers and other technical staff. Assign tasks and provide support and assistance to the development team.
- Provide assistance and support to other departments including Production, Quality and Technical as required. This could include major issues with newly developed products/processes, resource balancing and major priorities. Participate in CAPA, Audit, Validation, MRB/NCMR activities if required.
- Third level qualification in Engineering or Science, preferably in Mechanical or Biomedical, Minimum Bachelor’s Degree (Level 8) in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent).
- Minimum 6 years experience in a Medical Devices environment with knowledge of medical device products and associated manufacturing processes, in particular with extrusion-based catheter assemblies.
- Design capability with CAD systems (Solid Edge).7
For further information contact Sean on 094 90 29944.