Sr. Systems Engineer I

Date: May 12, 2022

Location: Santa Barbara, CA, US, 93111

Company: Arthrex

Requisition ID: 52777 
Title: Sr. Systems Engineer I - ACT 
Division: Arthrex, Inc. (US01) 
Location: Santa Barbara, CA 

 

 

 

 

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Systems Engineer I responsible for 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 to 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, 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 to all ISO, IEC, and regulatory standards required for a given product or assignment. 
  • Manage 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.

 

Knowledge, Reasonability, Discretion/Latitude:

  • Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices.
  • Develops solutions to a variety of complex problems.  May refer to established precedents and policies.
  • Work is performed under general direction.  Participates in determining objectives of assignment.  Plans schedules and arranges own activities in accomplishing objectives.  Work is reviewed upon completion for adequacy in meeting objectives.

 

Skills:

  • Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
  • Manufacturing process and inspection knowledge required.
  • Experience with project management methods
  • Strong technical communicator
  • Knowledgeable of medical device product development lifecycle from concept through production release.
  • Ability to lead complex, cross functional teams.
  • Contributes to strategic discussion that addresses both business and technical risks
  • Technical knowledge in development methodologies, design, and project implementation.
  • Historical perspective on orthopedic surgery principals, theories, and products preferred.
  • Knowledgeable of application of systems engineering to the medical device industry. 

 

Education/Experience:

 

  • 5 + Years of experience
  • BS Degree Engineering (or equivalent experience)
  • MS Preferred

 

 

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 health care 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.

 

 

 

 

 

 

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.


Nearest Major Market: Santa Barbara
Nearest Secondary Market: Santa Maria

Job Segment: Medical, Orthopedic, Manufacturing Engineer, Systems Engineer, Engineer, Healthcare, Engineering