Engineer Sr. I – QA Design

Join Arthrex as a Senior Design Assurance Engineer (Remote)

Are you a passionate and experienced Design Assurance Engineer looking to make a real impact in the medical device industry? Arthrex, a global leader in orthopedic innovation, is seeking a talented individual to join our team. In this remote role, you’ll play a crucial part in ensuring the quality and safety of our cutting-edge medical devices, helping surgeons treat their patients better.

What You’ll Do:

As a Senior Design Assurance Engineer, you will:

• Lead design assurance efforts for new product development, focusing on the quality aspects of integrated software, electrical, and mechanical device characteristics.
• Spearhead compliance efforts for electrical safety, environmental standards, and emissions in alignment with national and international regulations.
• Ensure the accuracy and traceability of documented design requirements and outputs throughout the product development lifecycle.
• Provide expert guidance on regulations and standards, serving as a valuable resource across various disciplines within the product design process.
• Supervise and coordinate the work of other design assurance team members to support department and design project goals.
• Contribute to the development, modification, and enhancement of design processes and the quality management system.
• Lead product risk assessment activities using industry-standard tools like FMEAs, FTA, and Hazard Assessments, based on applicable standards (e.g., ISO 14971).
• Provide guidance to design teams on usability/human factors engineering principles, including standards (IEC 62366) and FDA guidelines.
• Facilitate the planning, execution, and review of verification/validation (V&V) activities, ensuring adequate inputs to the V&V process.
• Coordinate the design assurance aspects of Design to Manufacture Transfer, including inspection methods, drawing reviews, and training of manufacturing personnel.
• Ensure compliance of the design history file (DHF) and support the transition of design projects into sustaining engineering.
• Support design-related corrective and preventative activities for projects in the pre-sustaining phase.
• Establish and maintain Risk Management Files.

What You’ll Bring:

We are looking for a highly motivated individual with:

• A Bachelor’s degree in Engineering (Biomedical, Mechanical, or Electrical preferred).
• 5+ years of design assurance/quality assurance experience in a medical device or other highly regulated industry.
• In-depth knowledge of ISO and FDA design and development quality requirements.
• Strong technical knowledge in development methodologies, design quality analysis, and project implementation.
• Proficiency in assessing manufacturing quality requirements of new product concepts.
• Experience with DHF & Technical File structure and maintenance.
• Knowledge of Electro-Medical safety standards (IEC 60601-1, IEC 60601-1-2, etc.).
• Hands-on experience in global medical device regulatory requirements for Electro-Surgical Devices is a plus.
• Essential knowledge of Risk Management for medical devices (ISO 14971).
• Proficiency with PC operations and the Microsoft Office suite; experience with Minitab, SAP, Codebeamer, and Windchill is preferred.

Why Arthrex?

Arthrex is more than just a company; it’s a community dedicated to innovation and making a difference in the lives of patients. We offer:

• A competitive salary range: $109,250 – $156,687
• An exceptional benefits package including:
  • Medical, Dental, and Vision Insurance
  • Company-Provided Life Insurance
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • $7,500.00 Employee Referral Bonus
  • And much more!
• The opportunity to work on challenging and rewarding projects.
• A supportive and collaborative work environment.

Ready to Join Our Team?

If you’re a driven and results-oriented engineer with a passion for quality and a desire to contribute to a company that is truly making a difference, we encourage you to apply! Become a part of Arthrex and help us continue Helping Surgeons Treat Their Patients Better™.