Engineer I QA Design - Orthobiologics

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. 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, QA Design - Orthobiologics for our global headquarters in Naples, FL.

The Engineer I QA Design 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.

• 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 Time Off
• 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.