Process Development Engineer

Process Development Engineer – Galway 

The PD Engineer will be an experienced engineer with good knowledge of medical device development for interventional cardiology or other percutaneous catheter-based therapies. Key responsibilities include supporting the development and implementation of manufacturing and assembly processes associated with the company’s pVAD catheter, as well as working with the suppliers of catheter components and sub-assemblies. The PD Engineer will work closely with his/her counterparts responsible for device development and characterisation, other development functions, and Quality.

Key Responsibilities

• Develops manufacturing processes, materials, and methods as part of the CardiacBooster product development team, using in-house and external development paths
• Designs, specifies, procures and qualifies process fixtures and equipment
• Develops Work Instructions and other supporting documentation (e.g. calibration and maintenance documents) for manufacturing processes
• Executes process characterisation and validation activities
• Development of pFMEA and risk documentation associated with the device and its manufacture.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements
• Works with internal cross-functional teams and contract manufacturers
• Executes project plans, tasks and deliverables. Manages time to meet project deadlines.
• Uses structured problem-solving techniques and statistical methods for data driven analysis and decisions

Skills, Qualifications & Experience

• Minimum of three years of medical device development experience, and have either a primary or Master’s Degree in a relevant engineering discipline such as polymer, mechanical, manufacturing or biomedical engineering.
• Experience in fabrication and manufacture of catheter based medical devices; experience in stent and/or large calibre delivery systems is an advantage.
• New product introduction skills in medical devices are a must. In particular:
  • Fixture and equipment design & specification
  • Validation of processes and process equipment
  • Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes
• Working knowledge of materials and process capabilities used in catheter based medical devices
• Working knowledge and ability to use statistical techniques, Six Sigma and Minitab analysis to support manufacturing processes.
• Proficiency in Solid Works 3D modelling would be an advantage
• Experienced in ISO 13485 compliant manufacturing & Risk Management tools e.g. pFMEA
• Ability to work within a team; fully motivated to achieve and demonstrate best practices in line with company objectives.
• Excellent verbal communication skills to enhance collaboration and written skills to prepare/execute/communicate plans and reports
• Strategic Planner with successful scheduling & execution results