Senior Product Development Engineer
The Senior Product Development Engineer will manage and take a lead role on a range of challenging engineering projects, with active project involvement from initial concept discussions and scoping with a client, through to delivery of products to market. The role operates as part of a multidisciplinary team including quality and operations and requires extensive interaction with both clients and suppliers.
The ideal candidate will have significant product and process development experience in the medical device sector.
- Review of clients RFQ documents, specifications, requirements and generation of quotes.
- Provide technical feedback during frequent technical contact with customers to optimise product design.
- Compile project plans and lead a team in accordance with planned activities, budget and timelines. Actively project manage across product life cycle stages and to client requirements.
- Generation of component, packaging and assembly drawings in CAD/Solidworks.
- Define in-process testing and process controls.
- Work with the customer in their development of design validation, shelf life / transportation studies and sterilisation validations.
- Develop risk-based process validation master plans, preparing protocols, data collection, data analysis and reports.
- Writing and approving technical documentation, including manufacturing and testing procedures, bills of material, data sheets etc.
- Delivery of high-quality presentations to clients and articulation of complex design / mechanical solutions.
- Develop existing suite of processes and equipment.
- Degree in Mechanical Engineering, Biomedical Engineering (or equivalent degree) or higher.
- Minimum 5 years post graduate relevant engineering/ design experience in the medical device sector with a proven track record of leading teams in a multidisciplinary environment.
- Proficient in SolidWorks /3D CAD.
- Practical knowledge of manufacturing processes including injection moulding, extrusion, assembly methods and design for manufacture methodologies.
- Knowledge of the regulatory requirements associated with medical device development and experience working within Quality Management Systems such as ISO 13485.
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / email@example.com
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