Austin Vita are excited to be representing a well-established brand in the Medical Device Industry. This is a great opportunity to be involved with the production of our clients' new project.
The role is based at the clients' site in Cardiff. Our client is a global brand, who produce surgical Medical Devices.
To be successful in this role, you should have experience with Analogue Design. Additionally, an understanding of EMC is a required skill. Experience in Schematics and PCB Layout, ideally Altium, is preferable. On top of this, it is essential to have experience within a highly-regulated environment, preferably Medical Devices as the role will include the handling of technical documentation.
- Lead the design, development and prototyping of new products in accordance with company Product Development Process (PDD) requirements to meet functional, clinical, customer and manufacturing requirements.
- The provision of peer review and technical support to other engineers in order to improve the overall engineering ability and knowledge within the department and company.
- Provision of formal Technical Approval for all project output to ensure compliance with agreed specifications and all relevant regulatory standards. - Research and maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
- Lead in the evaluation and documentation the feasibility, reliability and risk of concepts and/or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements.
- Develop timelines and cost estimates for development tasks and appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule.
- Generate and review design history file documentation in compliance with GMP, QSR, ISO and company PDD requirements throughout the project life cycle to ensure the design is fully documented.
- Coordinate vendor activities relative to communication of specifications, development schedules and progression tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly.
- The delivery of manufacturable designs acceptable to operations by applying Design for Manufacture principles and feedback from manufacturing engineers, external suppliers and other sources
- Bachelor's degree in Electronic Engineering or equivalent and minimum of six years of relevant engineering experience in high technology regulated industry.
- Experience in development of real-time embedded systems
- Detailed knowledge of up to date software development and test methods
- Familiarity with software configuration management tools, design tools, and peer review
- Ability to understand electronic circuit schematics.
- Excellent written and oral team communication skills.
- Competency in material processing technologies and wide range of part manufacturing methods.
- Ideally GMP, ISO 13485, IEC62304, IEC60601 and QSR knowledge as practiced in the medical device industry
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.