Engineer Senior I - QA Design

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

The Engineer Senior I - QA Design at Arthrex is responsible for leading design assurance efforts within product design and development for new product introduction projects, particularly focusing on quality aspects of integrated software, electrical, and mechanical device characteristics. This role involves ensuring compliance with design requirements, regulations, and standards throughout the product development lifecycle, while also supervising and coordinating the work of others in the design assurance team.

Responsibilities

• Lead design assurance efforts within product design and development for new product introduction projects.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Provide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines.
• Supervise, assign, and coordinate the work of others within the design assurance team.
• Provide input into and lead addressing of lessons learned to support development and improvement of design processes.
• Lead product risk assessment activities through application of applicable standards and tools.
• Display working knowledge and provide guidance to design teams in usability/human factors engineering principles.
• Facilitate the planning, execution, and review of verification/validation activities.
• Lead and coordinate the design assurance aspects of Design to Manufacture Transfer.
• Ensure required outputs of the design control process are met, including compliance of the design history file.
• 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 degree preferred.
• 5+ years design assurance / quality assurance experience in a medical device or other 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)