Engineer Sr. II - QA Design

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

The Engineer Sr. II - QA Design at Arthrex is responsible for leading design assurance efforts within product design and development for new medical device projects. This role emphasizes quality aspects of integrated software, electrical, and mechanical device characteristics, ensuring compliance with national and international regulations. The position involves supervising a design assurance team, conducting risk assessments, and facilitating verification and validation activities to support the development of FDA Class I and II, and EU Class I, IIa, IIb, and III medical devices.

Responsibilities

• Lead design assurance efforts within product design and development for new product introduction projects.
• Ensure compliance for electrical safety, environmental, and emissions for electrical equipment projects.
• Document design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Act as a resource for understanding and implementing regulations/standards within the product design process.
• Supervise and coordinate the work of others within the design assurance team.
• Lead product risk assessment activities using applicable standards and tools.
• Provide guidance on usability/human factors engineering principles and compliance standards.
• Facilitate planning, execution, and review of verification/validation activities.
• Coordinate design assurance aspects of Design to Manufacture Transfer, including inspection methods and training of manufacturing personnel.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.

Requirements

• Bachelor's degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering preferred.
• 8 years design assurance/quality assurance experience in a medical device or highly regulated industry required.
• Working knowledge of ISO and FDA design and development quality requirements.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.
• Proficiency in assessing manufacturing quality requirements of new product concepts.

Nice-to-haves

• Technical knowledge in GD&T & DOE preferred.
• Hands-on experience with SAP and Agile preferred.

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)