Collins McNicholas

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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