Senior QA Design Engineer – Medical Devices (FDA/ISO)

Arthrex; Santa Barbara (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Voluntary Life Insurance

Flexible Spending Account (FSA)

Supplemental Insurance Plans

Matching 401(k) Retirement Plan

Annual Bonus

Wellness Incentive Program

Free Onsite Lunch

Tuition Reimbursement Program

Paid Time Off

Employee Assistance Provider (EAP)

Job summary

Arthrex, Inc. in Santa Barbara, CA is seeking a Sr. I Engineer – QA Design to drive design assurance across product design and development, ensuring regulatory and patient safety standards are met throughout the lifecycle.

You will lead risk assessments, usability, V&V planning, design transfers, and DHF compliance, collaborating with electrical, mechanical, and software teams to bring new and sustaining medical devices to market.

Qualifications

• Bachelor’s degree in Engineering is required; Biomedical/Mechanical/Electrical preferred.
• Minimum 5 years in design assurance/quality in medical devices.
• Working knowledge of ISO and FDA design and development quality requirements.

Responsibilities

• Lead design assurance efforts for new product introductions with software/electrical/mechanical focus.
• Lead compliance for electrical safety and emissions per regulations.
• Ensure traceability of design requirements across development lifecycle.
• Lead design teams on usability/human factors per IEC 62366 and FDA guidelines.
• Plan, execute, and review verification/validation activities.
• Drive Design to Manufacture Transfer with inspection methods and training.
• Ensure DHF outputs meet design control requirements.
• Support corrective and preventive actions pre-sustaining.

Skills

Design Assurance

FDA Regulations

ISO Standards

Risk Assessment

V&V Planning

Electrical/Mechanical/Software

GD&T

DOE

SAP

Windchill

CodeBeamer

CAD/CAM

Education

Bachelor's degree in Engineering

5 years design assurance experience in medical devices

Tools

SAP

CodeBeamer

Windchill

CAD/CAM

Job description

Arthrex, Inc. in Santa Barbara, CA is seeking a Sr. I Engineer – QA Design to drive design assurance across product design and development, ensuring regulatory and patient safety standards are met throughout the lifecycle.

You will lead risk assessments, usability, V&V planning, design transfers, and DHF compliance, collaborating with electrical, mechanical, and software teams to bring new and sustaining medical devices to market.