Biomedical Engineer

We’re currently recruiting for an exciting opportunity with Innovative Medical Device client based in Dublin 8.

Key responsibilities:

• Work closely with project Lead and Product Development team to develop, build and test next generation medical devices.
• Support product development from concept generation through to post-production.
• Support design and technology transfer from product development to manufacturing by proactively working with stakeholders from manufacturing and quality.
• Provide support to Manufacturing to facilitate efficient operations within the production area, to optimise existing processes and to ensure that production goals are met.
• Oversee the analysis of hardware failures from the field and participate in associated corrective and preventive actions.
• Work closely with the Product Development Team to design, develop, build and test current and next generation medical devices.
• Participation in the drafting of test protocols may be required, in addition to documenting test results and generating test reports. Testing may include mechanical, electrical, performance, user interface / usability and software.
• Perform necessary design activities through utilization of 3D and 2D CAD software.
• Analyse and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems.
• Report writing and preparing presentations to communicate findings.

• Degree in Biomedical Engineering, Mechanical Engineering or similar discipline with 3+ years ; medical device industry experience in a product development or manufacturing role.
• Experience with embedded C and C++ and embedded fundamentals.
• Experience with Microcontrollers and popular interfaces such as Bluetooth, UART etc.
• Proficient in using Solid Works, Altium or equivalent 3D CAD design package.
• PC Literate (word processing, spreadsheets, data base) and a good knowledge of Project Management tools.
• A good understanding of quality management system principles (e.g. ISO 9001 or ISO 13485) and/or FDA quality system regulation processes according to 21 CFR part 820.
• A team player with excellent interpersonal and communications skills, with the ability to solve problems ad-hoc.
• Experience in the development of test methods and associated product testing.
• Excellent analytical skills, ability to plan, organise and implement multiple concurrent tasks.
• Ability to present ideas and concepts clearly and effectively to all levels of the company.
• Excellent planning and coordination skills and capable of initiating and leading change.

• Relevant experience in the medical industry is preferable.
• Strong attention to detail and commitment to quality.
• Strong analytical problem-solving skills and able to make efficient decisions.
• Continuous improvement mindset & experience of Lean principles.
• Proven track record for identifying and implementing improvements to processes and mitigate risk.
• Knowledge and understanding of international safety standards such as IEC 60601, ISO
• 14971 and ISO 10993.
• Experience in the development of test methods and associated product testing.
• Experience in the application of statistical principles within an engineering discipline, with experience in the use of statistical software such as R, STATA or Matlab.
• Ability to work effectively under pressure in a fast paced environment.
• Willingness to travel internationally as required.