Engineer I QA Design - Orthobiologics

Arthrex•Pelican Bay, FL

2d•Onsite

About The Position

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™.

Requirements

Bachelors degree in Engineering required
Experience in Design Quality Assurance in a medical device or other highly regulated industry preferred.
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.
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
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.

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.