Galway, Connacht, Ireland · On-site
The Product Engineer will hold a role within the R&D team and work in collaboration with ProVerum Operations, Quality, Regulatory and Clinical teams to execute R&D projects in support of the different functions. The role…
Skills: Medical device industry, Troubleshooting, CAPA, NCR investigations, Device returns investigations
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The Product Engineer will support the Operations team in sustaining manufacturing lines through troubleshooting and process improvement activities. They will also manage device returns investigations and ensure all documentation complies with ISO 13485 quality standards.
Candidates must hold a minimum level 8 degree in Engineering or a related technical field. At least 3 years of experience in the medical device industry and proficiency in CAD software are required.
The Product Engineer will hold a role within the R&D team and work in collaboration with ProVerum Operations, Quality, Regulatory and Clinical teams to execute R&D 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 R&D 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
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