This site uses cookies. To find out more, see our Cookies Policy

Engineer Associate - Product Development in City of Industry, CA ,  at Arthrex

Date Posted: 3/28/2018

Job Snapshot

Job Description


Requisition ID:
40286
Title:
Engineer Associate - Product Development
Division:
Arthrex California Inc
Location:
ACI City of Industry, CA

Summary Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

MAIN OBJECTIVE:

Under the direction and supervision of Engineer Principal at ACI, responsible for full life cycle design and development of Class I medical devices, which includes initiation, design, development, execution, and product maintenance. The projects you work on will be tailored to the specific Arthrex project team for which they belong (i.e., Knee/Hip; Distal Extremity; or Upper Extremity). Additional responsibilities will include design and development of mfg. and assembly tooling and fixturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

  • Learns, understands and become proficient with Arthrex Design Control and Quality procedures.
  • Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
  • CAD Drafting and drawing maintenance of new and existing products using Solidworks.
  • Maintains files and documentation of engineering related materials.
  • Recommends alterations to development and design to improve quality of products and/or procedures.
  • Determines budgets and timelines for assigned projects.
  • Maintains design history file for engineering projects.
  • Initiates, completes and maintains Change Requests for engineering projects.
  • Provides Regulatory department technical support for engineering projects as needed.
  • Supports Marketing and Product Management with technical information to be used for training and marketing of products.
  • Supports the machine shop and Manufacturing suppliers to provide processing improvements.
  • Determines necessity of testing and initiates testing of new and existing products.
  • Writes and submits reports on testing, product validation etc.
  • Reports progress and status of assigned projects on a timely basis to Engineering Principal at ACI. 
  • May be required to travel to attend trade shows, distributors, customers, or other Arthrex members.
  • Researches materials, new suppliers, components, parts and competitor products.
  • Assists company personnel with engineering related issues wherever needed.

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:

Bachelors of Science degree in Mechanical or Biomedical Engineering required. 

Minimum of two years medical device design/development experience or equivalent preferred.

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

Knowledgeable of FDA and ISO guidelines for the development of medical devices required.

Limited use and/or application of basic principles, theories, and concepts. 

Limited knowledge of industry practices and standards.

Experience in design simulation with analysis tools such as FEA preferred

Manufacturing process knowledge preferred.

Project management and communication skills training preferred.

Working knowledge of anatomy from an orthopedic standpoint preferred.

Machine, Tools, and/or Equipment Skills:

Knowledge of surgical equipment and instrumentation required

Proficient with Solidworks 3D modeling software, PC, MS Office, etc. required.

Experience with machine shop (machining and manufacturing equipment) preferred.

Knowledge of mechanical testing equipment (Instron) preferred

Reasoning Ability:

Solves routine problems of limited scope and complexity following established policies and procedures.

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 to 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.