Engineer I QA Design

Arthrex GmbH; Naples (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

401(k) Retirement Plan

Annual Bonus

Paid Parental Leave

Job summary

Arthrex, Inc. in Naples, FL is seeking an Engineer I, Design Quality to drive Design Assurance within engineering teams for FDA/European medical devices.

You will contribute to design, development transfer and post-market surveillance, lead risk assessments, verify/validate activities, and ensure DHF compliance.

This on-site role offers exposure to a global medical device leader and opportunities to influence quality across software, electrical and mechanical aspects.

Qualifications

• Bachelor's degree in Engineering is required.
• Experience in design quality assurance for medical devices is preferred.
• Knowledge of ISO 13485 and FDA regulations is a plus.

Responsibilities

• Execute design assurance for new product introductions with emphasis on quality of software, electrical, and mechanical device characteristics.
• Lead compliance efforts for electrical safety, environmental, and emissions for devices.
• Ensure traceability of design outputs throughout the development lifecycle.
• Support design processes with regulatory standards and DHF documentation.
• Lead risk assessment activities using ISO 14971, FMEA, and fault analysis.
• Guide usability/human factors per IEC 62366 and FDA guidance.
• Coordinate verification/validation planning, execution, and review.

Skills

Design Quality Assurance

Regulatory compliance

Medical devices

Risk assessment

Education

Bachelor's degree in Engineering

Tools

Design Controls

Job description

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for an Engineer I, Design Quality who is responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer, and post-market surveillance of FDA Class I and II, EU, Class I, IIa, IIb and III medical devices.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities

• Execute design assurance responsibilities within product design and development for new product introduction projects with an emphasis in quality aspects of integrated software, electrical, and/or mechanical device characteristics, as appropriate for the specific area of position focus.
• For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Actively support understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.
• Provide input into and lead addressing of lessons learned to support development, modification, and improvement of design processes and quality management system.
• Lead product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
• Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance.
• Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
• Coordinate the design assurance aspects of Design to Manufacture Transfer including generation of inspection methods, drawing reviews, determining key product indicators/essential requirements and, where appropriate, training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
• Ensure required outputs of the design control process are met, including compliance of the design history file (DHF), and support transition of the design project into sustaining engineering.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.

Education and Experience

• Bachelors degree in Engineering required
• Experience in Design Quality Assurance in a medical device or other highly regulated industry preferred.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Arthrex 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 LeavePaid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Making People Better at Arthrex

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Job Details

Date: Sep 11, 2026

Requisition ID: 67652

Salary Range:

Job title: Engineer I QA Design

Engineering Location: Naples, FL, US, 34108

Nearest Major Market: Naples

Job Segment: Medical Device Engineer, Medical Device, Quality Assurance, QA, QA Engineer, Engineering, Healthcare, Technology, Quality