Software Quality Assurance Engineer
Permanent
Tipperary
The role:
Responsible for supporting Manufacturing and R&D projects. Projects include both implantable, external and capital systems.
Responsibilities:
• Provide quality system oversight of any new Software/Firmware code developed on site to procured from an external vendor to be used in or the manufacturing of company medical devices. Develop Firmware solutions based on requirements.
• Work closely with the software/firmware team to recommend architecture of new products from a Hazard Analysis, DMFEA, SW Security and Industry standards (such as 62304 etc.) perspective.
• Executes SW validations for new manufacturing equipment brought into the plant.
• Functions as an independent SW reviewer for validation protocols and reports authored by other engineers.
• The role will involve frequent interactions with external entities in clinical/non-clinical settings to complete research activities, identification / development of system requirements and presentations on work product / progress to senior leadership team.
Skills Experience and Qualification:
• Familiar with Agile SW development process
• Level 8 in Computer Science Engineering / Electronics Engineering/ Biomedical Engineering
• Familiar with Industry standards for medical device SW ( IEC62304) and SW Security Initiatives
• Familiar with C++, C# and embedded C programing languages
• Able to work independently and as part of a team
• Innovative thought process
• Strong presentation skills.
For a confidential discussion and more information on the role, please contact Phil on 021 4911064 or email phil.burchell@collinsmcnicholas.ie
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