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Sr Design Assurance Engineer - Mechanical in Naples, FL ,  at Arthrex

Date Posted: 3/28/2019

Job Snapshot

  • Employee Type:
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Requisition ID:
Sr Design Assurance Engineer - Mechanical
Arthrex, Inc.
Naples, FL

Sr. Design Assurance Engineer

We are looking for a dynamic and inspiring Senior Design Assurance Engineer to join and support our growing corporate Design Quality team.  We are looking for an experienced professional to continue our development and enhancement of efficient, best in class, systems supporting new product development and design controls.  You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to supporting continued business growth and expansion initiatives.  This is an opportunity to use your background and experience to leave a lasting mark on a fast-paced, growth-oriented, private organization.  Candidates must be committed to excellence in all areas and take pride in providing elegant and scalable solutions to complex problems, supporting quality and patient safety throughout Arthrex’s various business interests.

About You: 

You are:

  • Motivated, driven to learn, and thrive in a dynamic and fast-paced environment;
  • Proven in your track record for team engagement and leadership in design assurance and risk management processes;
  • Dedicated to seeking out opportunity for the continuous improvement of processes and programs, striving for efficiency, simplicity, and elegance while maintaining high quality and compliant outputs;
  • Promoting of a collaborative, team-based, atmosphere in an open and modern work environment;
  • Possessing a keen sense of what “good” looks like and are adept at coaching design team members & business partners towards it;
  • Constantly open to challenges, problem solving, and partnership to support organizational growth and initiatives.

Some More Details:

  • Hands-on experience leading the quality aspects of new product design and risk management programs;
  • Informed regarding the impact of human factors and usability on design processes, outputs, and documentation;
  • Full understanding of state of the art / best practice and requirements governing design controls and risk management programs;

About Us

Arthrex is a global medical device company and a leader in new product development, commercialization, and medical education in orthopaedics. As members of the Pre-Production Quality team, you will be the front-line in ensuring complaint product designs, patient safety, and supporting the organization in its mission of helping surgeons treat their patients better.  


Main Objective:

Responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surevillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals.

Essential Duties and Responsibilities:

  1. 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.
  2. For electrical equipment / active device projects, lead compliance efforts for electrical safety, environmental, and emissions in accordance with national and international regulations.
  3. Ensure appropriateness of documented design requirements and outputs while ensuring traceability throughout the product development lifecycle.
  4. 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.
  5. Supervise, assign, and coordinate others / the work of others within the design assurance team to support the department and design projects and goals.
  6. Provide input into and lead addressing of lessons learned to support development, modificiation, and improvement of design processes and quality management system.
  7. 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.
  8. Display working knowledge and provide guidance to design teams in the area of usability/human factors engineering priniciples including standards (IEC 62366) and FDA guidance for compliance.
  9. Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
  10. 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.
  11. 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.
  12. Support design-related corrective and preventative activities for projects in the pre-sustaining phase. 

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

  • Bachelor of Science Degree in Engineering from an ABET accredited program. Biomedical, mechanical, or electrical engineering degree preferred.
  • Minimum 7 years design assurance / quality assurance experience in a medical device or other highly regulated industry.

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.

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