Product Engineer

The Product Engineer will hold a role within the RD team and work in collaboration with ProVerum Operations, Quality, Regulatory and Clinical teams to execute RD projects in support of the different functions. The role will be based at the ProVerum manufacturing facility in Galway. The Product Engineer will report to the Senior RD Manager.

Role/Responsibilities

• Support Operations team in sustaining manufacturing line, by contributing to troubleshooting (real-time during builds, and through CAPA and NCR investigations) and process improvement activities.
• Take ownership of Device Returns investigations, including execution of returned device testing and associated test method development.
• Become SME in test methods to support manufacturing and regulatory submissions.
• Ensure all work is carried out in compliance with Quality, Regulatory and company policies and systems.
• Compile technical documentation to support product and manufacturing updates in accordance with ProVerum’s ISO 13485 Quality Management System.

Skills/Experience

• Minimum level 8 degree in Engineering, or related technical field
• At least 3 years previous related experience in the medical device industry
• Demonstrated analytical problem-solving abilities
• Good working knowledge of Microsoft Office including MS Project or similar
• Experience with Solidworks CAD software package or similar
• Ability to work effectively both independently and as part of a cross-functional team
• Strong interpersonal and organizational skills
• Experience in test method development and manufacturing process development
• Good working knowledge of medical device materials and processes, in particular knowledge of catheter technologies and associated assembly processes an advantage