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Reliability Engineer

1 month ago

Dexter, Maine, United States LanceSoft Full time
Job Title: Reliability Engineer

We are seeking a highly skilled Reliability Engineer to join our team at LanceSoft. The successful candidate will be responsible for developing and implementing technical reliability studies and evaluations of engineering design concepts.

Key Responsibilities:

  • Develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

Requirements:

  • University Degree in Engineering, Science, or technical field.
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
  • Expertise in CAPA compliance & investigation techniques.
  • Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive, and MDSAP.
  • Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.

Working Conditions:

  • May work independently under limited supervision to determine and develop approach to solutions.
  • Coaches and reviews the work of lower-level specialists; may manage projects/processes.