Our client an exciting and growing medical device company currently seeks a Senior Product Development Engineer to join their team. Reporting to Product Development Manager, the product development manager will provide key support to the Product Development function in developing products, processes, materials requirements and equipment in order to achieve design brief. Ensure the company's design control responsibilities are fulfilled, specifically development and design verification phases and related sustaining engineering activities
- Lead the Design and Development process for both new and transfer products in compliance to internal procedures including EU and FDA requirements from Development phase up to Transfer to Production.
- Gathering clinical/user needs and translation into technical specifications.
- Component/assembly design and preparation of associated drawings and specifications.
- Assist Research & Process Technologies function on developing early prototypes.
- Transform early feasibility design into design freeze stage by building, testing and refining all design aspect.
- Test method development; identification and procurement of equipment for inspection and test, test method validation and training.
- Identify product testing required; create design verification and validation plans, protocols and reports including specifically advising on sample sizing; Stability and Transportation testing
- Generation, analysis and interpretation of test data.
- Aid with the preparation of risk management files including Use and Design FMEAs as required in accordance with company procedures and EN ISO 14971.
- Assist Design Assurance on Design History files.
- Generation and/or review of technical documentation / change requests related to design activities.
- Developing and delivering project plans to performance, time and cost targets.
- Liaising with external resources to achieve project goals.
- Application of Engineering methodologies in device design and test method development
- Structured Problem Solving and Decision Making
- Translating clinical/user needs into technical specifications.
- Design Verification including product specific functional tests, stability and transportation testing.
- Excellent working knowledge of statistical methods commonly used in product/process design and validation.
- Application of standard regulatory requirements (CE & FDA)
- Risk Management; Design and Use FMEA
- Project management through all phases of the Design & Development processes
- Excellent presentation, verbal and written communication skills.
- Change control management; design, process and system.
- Quality of Work; maintains high standards despite pressing deadlines.
- Mechanical or Biomedical engineering degree or equivalent.
- Minimum 5 years' experience in medical device design/development or similar role in a medical device company.
- Strong technical aptitude with a good understanding of fundamental engineering principals and materials.
- Broad knowledge of materials and processes used in medical devices.
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Working knowledge of the Medical Device Directive (93/42/EEC) and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322