Senior Engineer, QA Design - Arthroscopy (Lower Extremeties)

Arthrex, Inc.; Naples (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Arthrex, Inc. is seeking a Senior Engineer, Design Quality, Lower Extremities for its global headquarters in Naples, FL.

The role interfaces with engineering teams to apply Design Assurance principles across design, development transfer, and post-market surveillance of FDA class I-III medical devices. You will lead design assurance activities, drive risk assessment, and ensure regulatory and quality requirements are met throughout the product lifecycle, including design to manufacture transfer

Qualifications

• Bachelor’s degree in Engineering required.
• Minimum 5 years design assurance/quality assurance experience in a medical device or highly regulated industry.

Responsibilities

• Lead design assurance efforts for new product introduction with emphasis on quality.
• Ensure traceability of design requirements throughout the development lifecycle.
• Lead risk assessment activities using ISO14971, FMEAs, FCA, Hazard Assessment.
• Provide guidance on usability/human factors per IEC 62366 and FDA guidance.
• Oversee verification/validation planning, execution, and review.
• Coordinate design to manufacture transfer and inspection method generation.

Skills

Design assurance

Regulatory knowledge

V&V planning

Risk assessment

Education

Bachelor's degree in Engineering

Tools

CAD/CAM

SAP

Agile

Job description

Arthrex, Inc.is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex isactively searching for a Senior Engineer, Design Quality, Lower Extremities for our global headquarters in Naples, FL . The Senior Engineer 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 in the achievement of company goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Lead design assurance efforts 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.
• Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
• Provide active leadership in understanding and implementing regulations/standards, acting as a resource to other disciplines, within the product design process from idealization through product retirement.
• Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
• 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.
• Lead and 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:

• Bachelor’s degree in Engineering required; Biomedical, Mechanical, or Electrical Engineering degree preferred.
• 5 years design assurance / quality assurance experience in a medical device or other highly regulated industry required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Working knowledge of ISO and FDA design and development quality requirements.
• Technical knowledge in development methodologies, design quality analysis, and project implementation.
• Proficiency in assessing manufacturing quality requirements of new product concepts.
• Technical knowledge in development methodologies, design, and project implementation, including but not limited to, GD&T & DOE preferred.

Machine, Tools, and/or Equipment Skills:

Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software. Hands on experience with SAP and Agile 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 inform ation as required by procedures.

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