Product Development Engineer

Arthrex California Inc - Industry, CA (30+ days ago)3.8

Requisition ID: 41270
Title: Engineer - Product Development
Division: Arthrex California Inc (US03)
Location: Walnut, CA

Main Objective: Under the general supervision of management, responsible for full life cycle design and development of Class I medical devices for the orthopedic industry, specifically arthroscopy. Responsibilities include research, initiation, design, development, execution, product maintenance and documentation.

Essential Duties and Responsibilities:
Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
Recommends alterations to development and design to improve quality of products and/or procedures.
Determines budgets and timelines for assigned projects.
Leads multifunctional new product project teams, as assigned by Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
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 assigned products.
Supports Manufacturing to provide processing improvements including design and development of assembly tooling and fixturing.
Initiates, completes and maintains Engineering Change Orders for engineering projects.
Determines necessity of testing and initiates testing of assigned products. Completes testing/product validation documentation.
Reports progress and status of assigned projects on a timely basis.
Researches materials, new suppliers, components, parts and competitor products.
May be required to travel to attend trade shows, distributors, customers, or other Arthrex facilities.

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 three years medical device design/development experience required.

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

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

Frequent use and general knowledge of industry practices, techniques, and standards.

General application of concepts and principles.

Frequent use and general knowledge of industry techniques, practices and standards.

Manufacturing process knowledge preferred.

Project management and communication skills training preferred.

Working knowledge of anatomy from an orthopedic standpoint preferred.

Experience in design simulation with analysis tools such as FEA preferred

Machine, Tools, and/or Equipment Skills:
Proficient with Solidworks 3D modeling software and MS Office required.

Experience operating manufacturing equipment and knowledge of mechanical testing equipment preferred.

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.