QA Design Engineer I, Orthobiologics — Medical Devices

Arthrex, Inc.; Naples (FL); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

FSA

Supplemental Plans

401(k) Match

Annual Bonus

Wellness Program

Onsite Clinic

Onsite Lunch

Tuition Reimbursement

Paid Time Off

Employee Assistance

Job summary

Arthrex, Inc. in Naples, FL is seeking an Engineer I, QA Design - Orthobiologics to drive design assurance within engineering teams for medical devices across the lifecycle.

You will lead verification/validation activities, ensure DHF compliance, and support design to manufacture transfer, with focus on regulatory standards ISO14971, IEC 62366, and FDA guidance. This role offers growth in a global medical device company.

Qualifications

• Design assurance responsibilities for new product introductions with emphasis on quality.
• Lead compliance for electrical safety and environmental emissions per regulations.
• Ensure traceability of design requirements throughout the lifecycle.

Responsibilities

• Execute design assurance for new product introductions with emphasis on quality aspects of device characteristics.
• Lead compliance efforts for electrical safety and environmental emissions for electrical equipment projects.
• Ensure documented design requirements and outputs have traceability across the lifecycle.
• Support understanding and implementing regulations/standards within the product design process from ideation to retirement.
• Provide input into and lead addressing lessons learned to improve design processes and the quality management system.
• Lead risk assessment activities using standards (e.g., ISO14971) and tools (FMEA, FTA, Hazard Analysis).
• Guidance on usability/human factors (IEC 62366) and FDA guidance for compliance.
• Coordinate verification/validation planning and execution and assess inputs to the V&V process.
• Oversee design to manufacture transfer, including inspection methods and training of manufacturing personnel.
• Ensure DHF outputs meet design control process requirements and support transition to sustaining engineering.
• Support design-related corrective and preventive actions in pre-sustaining phase.

Skills

Design Assurance

Regulatory compliance

FMEA

FTA

Hazard Analysis

Usability / Human factors

IEC 62366

V&V planning

Design to Manufacture Transfer

DHF Compliance

Education

Bachelor's degree in Engineering

Job description

Arthrex, Inc. in Naples, FL is seeking an Engineer I, QA Design - Orthobiologics to drive design assurance within engineering teams for medical devices across the lifecycle.

You will lead verification/validation activities, ensure DHF compliance, and support design to manufacture transfer, with focus on regulatory standards ISO14971, IEC 62366, and FDA guidance. This role offers growth in a global medical device company.