- Third level Qualification in Engineering or Science, preferably in Mechanical or Biomedical; Minimum Bachelor’s Degree in a Science / Technology / Engineering related discipline (Mechanical, Manufacturing, Automation or equivalent)
- Ideally design capability with CAD systems (Solid Edge)
- Ideally, 2-3 years previous experience in a Medical Devices environment with knowledge of medical device products and associated manufacturing processes, in particular with extrusion based catheter assemblies.
- Strong interpersonal and communications skills
- Motivated and Self-starting
- Ability to manage multiple tasks and adapt to changing, fast paced environment.
- High level computer skills including Microsoft Excel, Powerpoint andSolid Edge and MS Projectdesirable
Duties/Accountabilities (incl. Deputation):
This involves but is not limited to:
- Generation of product & tooling drawings to support Quotations, Prototyping and Process Development.
- Product and process concept generation, presentation, prototyping and development.
- Support on a technical level 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 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 handles through the official change control (ECR/ECO) procedures.
- Constantly review the 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.
- Train and develop junior 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 new products/processes developed, resource balancing and major priorities. Participate in CAPA, Audit, Validation, MRB/NCMR activities if required.
A Senior R&D Engineer position may exist for a minimum of 4 years experience.