Job Title: Process Development Engineer
Location: Parkmore, Galway
Company:
My client is a medical device company developing a new and innovative device to support the heart. Heart support devices are used by interventional cardiologists to stabilize patients in times of acute heart failure (cardiogenic shock) or patients undergoing high-risk coronary procedures (high-risk PCI). Their objective is to overcome the limitations of current assist devices by providing interventional cardiologists with a more effective and less invasive device. Founded in 2018 as a Radboud UMC spin-off, they are an enthusiastic team with diverse backgrounds and expertise located in the Netherlands and Galway, Ireland.
Job Description:
Support the development and implementation of manufacturing and assembly processes associated with the company's pVAD catheter, design feedback & input, as well as working with the suppliers of catheter components. The PD Engineer will work closely with counterparts responsible for device development and characterization, other development functions, and Quality. They will share the responsibility of realizing their full potential. The successful candidate will have entrepreneurial spirit, persistence, resourcefulness to succeed in a start-up environment, and the ability to work in a self-directed manner. They will have hands-on knowledge and experience in both the development of cardiovascular devices and the processes required to manufacture them.
Responsibilities: Develops manufacturing processes, materials, and methods as part of the 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) for manufacturing processes.Executes process characterization and validation activities.Becomes a technical expert in the assembly and manufacture of our products, providing technical guidance to other team members.Builds Quality into all aspects of work by maintaining compliance with all quality requirements.Works with internal cross-functional teams and contract manufacturers or design firms to ensure system design, architecture, and verification/validation meet design input.Supports cleanroom setup, fit-out & validation.Evaluates relevant process & manufacturing technologies and strategically identifies opportunities to implement them.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. Required Qualifications:
- 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 large calibre delivery systems is an advantage.
- Product and process development, and new product introduction skills in medical devices are a must, particularly:
Fixture and equipment design & specification.Validation of processes and process equipment.Development of Work Instructions and Calibration & Maintenance activities for manufacturing processes.
Does this sound like your next career move? For more info, forward your application or contact me at 087 0612325 OR ******
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