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Principal Systems Engineer in Santa Barbara, CA ,  at Arthrex

Date Posted: 6/26/2018

Job Snapshot

Job Description


Requisition ID:
39722
Title:
Principal Systems Engineer
Division:
Arthrex, Inc.
Location:
ACT Santa Barbara, CA

MAIN OBJECTIVE:

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.  Recognized as a technical leader and resource.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  1. Lead team efforts in establishing program design inputs and/or requirements, ensuring compliance to Arthrex QMS and global standards and regulatory requirements
  2. Lead teams in the management and completion of Design Control Documentation: Traceability Matrix; Risk Management File; Verification and Validation Plans and Protocols; etc.Develop best practices, processes, technologies for System Engineering
  3. Lead team efforts in product complaints review, root cause failure analysis activities
  4. Lead team efforts to develop, track and monitor functional systems needs and reliability throughout a products life cycle, making recommendations on corrective actions and/or potential enhancements.
  5. Develops and manages product compliance initiatives to relevant standards governing medical electrical equipment.
  6. Supports the execution of engineering changes, lifecycle changes and/or document changes prior to release.
  7. Supervises, assigns and/or coordinates scope and breadth of quality/regulatory testing to be performed to ensure compliance to all ISO and regulatory standards required for a given product or assignment
  8. Supports Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits.
  9. Contributes to efficient and effective program management
  10. Ensure alignment of internal and external customers.
  11. Some required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Incidental Duties:

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’s degree in Engineering or Science required.  Preferably in Physics, Biomedical, Electrical, Mechanical, or Chemical Engineering.

15 years experience in medical device product development or similar environment required. 

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

  • Expert Systems Engineering skills; experience with full product development cycle preferred.
  • Demonstrable experience with medical device product development from concept and testing to production release.
  • Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail
  • Ability to balance business and technical risks while remaining compliant with internal systems.
  • Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
  • Understanding of Design for Manufacturability, including manufacturing process optimization support, and Design for Cost.
  • Understanding of Design for Quality with tools such as FTA, FMEA, etc.
  • Manufacturing process knowledge preferred.
  • Awareness orthopedic surgery principles, theories, and products preferred
  • Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
  • Technical knowledge in development methodologies, design and test in support of program release.
  • Ability to confidently lead and/or support complex, cross functional teams independently.
  • Continuously seeking ways to improve complex systems of people, processes and/or technologies.

Machine, Tools, and/or Equipment Skills:

Experience with electrical medical equipment and accessories development and testing. Understanding of regulatory standards for technical specialty areas as electrical, mechanical, software, chemical and data transfer design standards.  Knowledge of surgical equipment and instrumentation, mechanical testing equipment, SolidWorks or other 3D modeling software.  MS Office, PC and Databases.

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 information as required by procedures.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

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.