Engineer Ii - Systems - Medical Device

Arthrex, Inc. is a global Medical Device company and a leader in new product development and medical education in orthopedics The Engineer II – Systems will be responsible for the full life cycle development of Class I and II Medical Devices, which includes initiation, design, development, execution, verification/validation, release, and product maintenance. Join our talented team at a global Medical Device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Develop system architecture documentation
• Establish design inputs and/or system-level requirements, ensuring compliance with Arthrex QMS and global standards and regulatory requirements
• Decompose product requirements into discipline-specific product specifications, collaborating with other engineering functions.
• Develop, track, and monitor functional systems needs and reliability throughout a product’s life cycle, making recommendations on corrective actions and/or potential enhancements.
• Perform and develop methods to objectively quantify system performance/function.
• Manage tradeoffs between performance, cost, and schedule.
• Integrate all components and subsystems into a functioning system
• Review design verification plan and procedures
• Develop and manage product compliance initiatives to relevant standards governing medical electrical equipment (IEC60601).
• Work with notified bodies (e.g. UL, TUV) to demonstrate product compliance to IEC60601
• Coordinate testing to be performed to ensure compliance with all ISO, IEC, and regulatory standards required for a given product or assignment. 
• Manage the completion of Design Control Documentation
• Support the execution of engineering changes, lifecycle changes, and/or document changes prior to release.
• Review product complaints and perform root-cause failure analysis
• Identify and pursue novel technology to support future strategic opportunities.
• Support Quality System Audits conducted by external agencies, such as FDA, Notified Body, and/or Regulatory Agency audits.
• Contribute to efficient and effective program management
• Ensure alignment of internal and external customers.
• 10-15% travel (domestic and international) may be required.

Focus on Reliability:

• A significant portion of this role may be involved in the following tasks concerning reliability testing and characterization with both hardware and software:
  • Root cause failure analysis
  • Design of Experiments (DOE) and cycle testing
  • Product Complaints and field failures analysis
  • Test fixture design and support
  • Working with vendors and consultants on rapid prototyping and fixture design
  • Reliability analytics
  • Bug discovery
  • Managing a reliable lab space
  • Drafting and executing reliability test protocols
  • Creating design and process change proposals

About Arthrex

Arthrex Inc., a privately held company headquartered in Naples, Florida, is a global leader in orthopedic surgical device design, research, manufacturing, and medical education committed to one mission: Helping Surgeons Treat Their Patients Better™. Arthrex has pioneered the field of arthroscopy and sports medicine and innovates more than 1,000 new products and procedures every year to advance minimally invasive orthopedics worldwide.

Our core value is Making People Better. As a leading healthcare technology innovator, we are committed to making people’s lives better. The contributions we make to science and medicine have the potential to get a star athlete back in the game or improve the quality of someone’s life. It’s truly meaningful work.

Making People Better also signifies our corporate social responsibility and commitment to employees and communities. We make employees’ lives better through job security, educational and professional growth opportunities, unique benefits and amenities, and modern facilities that promote a vibrant and dynamic atmosphere of collaboration, mutual respect, and camaraderie. We also make important economic and philanthropic contributions to the communities we serve.

As a certified Great Place to Work® and one of the country’s Best Workplaces for Manufacturing and Production, Arthrex is proud of its award-winning, family business culture. With more than 6,000 employees around the world, we are growing and looking for candidates who champion our Arthrex Proud values of Innovation, Integrity, Dedication, Teamwork, and Competitive Spirit.

We invite you to explore our numerous exceptional benefits at careers.arthrex.com or visit us on LinkedIn, Facebook, Twitter, or Instagram.

Arthrex 2023 Benefits

• 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 Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• Volunteer PTO
• 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 or protected veteran status.