Reliability and Sustaining Engineer

Job description

This key position within the Sustaining Engineering group will enable the successful candidate to demonstrate their broad range of engineering skills in a fast paced dynamic environment. In working on these diverse products and projects the successful candidate will have the opportunity to work with other cross functional team members. 

Key Responsibilities:

  • Support the maintenance of product files and other relevant documentation to comply with quality standards
  • Review and analyse returned complaints in Complaints Returns Lab also providing investigation reports and root cause analysis
  • Coordinate and lead sustaining engineering projects
  • Provide customers with accurate complaint analysis trending and reports
  • Complete/assist in the assessment of design changes and product
  • Preparation of ad-hoc reports of product complaint and adverse event trends as required
  • Identify product improvement opportunities through product complaint, adverse event trend and customer feedback
  • Complete the execution of shelf life testing by maintaining records of testing dates and requirements
  • Complete/co-ordinate additional testing to meet new regulatory requirements/ customer requirements
  • Participate in internal and external quality system audits conducted by FDA and notified body representatives
  • Work within Sustaining Group ensuring regulatory requirements and changes are met
  • Apply new and existing technologies to provide the optimum delivery system design
  • Provide support to maintain compliance with all FDA, and other U.S., and international regulatory requirements as applicable, specifically in the Europe region


  • BS Degree in technical or scientific field or equivalent work experience 
  • Minimum 3-5 years' experience in medical device/ Pharma industry
  • Experience with engineering tools such as AutoCAD, Minitab
  • Excellent Technical writing experience in a medical device environment
  • Ability to interface with all levels of management
  • Self-starter who works well under minimal supervision
  • Attention to detail - reliable and consistent in review of records
  • Excellent communication skills (verbal and written). Communicates in a professional and courteous manner
  • Demonstrate product design and development experience, including experience of sustaining activities
  • Experience of compiling FMEA’s and conducting verifications and validations for medical devices products and processes


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent