About the role

  • Validation Engineer I supporting the AMI Validation Manager in process validation for medical devices. Focused on writing protocols and conducting validations for manufacturing processes.

Responsibilities

  • Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices
  • Responsible for writing of protocols and conducting validations of special processes, including laser marking, passivation, laser welding, molding, etc.
  • Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
  • Facilitate the execution of protocols by working closely with Engineering, Operations, Quality Control, and other manufacturing functions
  • Responsible for measuring validation parts and perform analysis of data generated from validations to evaluate process capability

Requirements

  • Bachelor’s degree in Engineering or Engineering related technology required
  • Experience in a Quality Control, Quality Assurance or Validation position in a Medical Device Company preferred
  • Knowledge of testing equipment, statistical methods, control plans
  • Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software

Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

Job title

Validation Engineer I

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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