Senior Engineer - Design Assurance - Remote

Overview

Arthrex, Inc. is a global medical device company seeking a Senior Engineer - Design Assurance to lead Quality Assurance functions and design development activities for Class I and II medical devices, ensuring compliance with FDA, ISO, and CMDR standards.

In Short

• Lead design assurance efforts for new product introduction projects.
• Ensure compliance with electrical safety and environmental regulations.
• Supervise and coordinate the design assurance team.
• Conduct product risk assessments and lead verification/validation activities.
• Maintain design history files and manage risk management documentation.
• Provide guidance on usability and human factors engineering principles.
• Facilitate the transition of design projects into manufacturing.
• Support corrective and preventive activities for design-related issues.
• Engage in continuous improvement of design processes.
• Collaborate with cross-functional teams to ensure quality standards are met.

Requirements

• Bachelor’s degree in Engineering required; preferred in Biomedical, Mechanical, or Electrical Engineering.
• 5+ years of experience in design assurance or quality assurance in a regulated industry.
• Knowledge of ISO and FDA design quality requirements.
• Experience with DHF and technical file structure.
• Proficiency in Microsoft Office, Minitab, SAP, Codebeamer, and Windchill preferred.
• Strong problem-solving and analytical skills.
• Ability to communicate effectively with team members and stakeholders.
• Hands-on experience with medical device regulatory requirements.
• Familiarity with risk management principles as per ISO 14971.
• Understanding of electrical and mechanical safety standards.

Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Flexible Spending Account (FSA)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Lunch
• Tuition Reimbursement Program
• Paid Parental Leave
• Employee Assistance Provider (EAP)