Engineer II - Mechanical - Medical Devices

Requisition ID:          60254 Title: Engineer II - Mechanical - Medical Devices Division: Arthrex, Inc. (US01) Location: INC Santa Barbara CA (ACT) (US17) Salary Range: Salary Minimum: $92,000.00 Salary Maximum:  $143,750.00

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Mechanical Engineer II will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, 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:

• Designs components or functional systems and modifies existing designs to develop or improve products as well as facilitate manufacturing operations.
• Recommends alterations to development and design to improve quality of products and/or procedures.
• Works with finance and extended team to determine budget for assigned projects.
• Works with project management and extended team to determine timeline for assigned projects.
• Primary mechanical resource on multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget. 
• Works with Systems Engineering to create and maintain design history file for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department technical support for assigned projects as needed.
• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
• Works with extended team to ensure design considers the needs of internal stakeholders (Manufacturing, Service, Quality, Sourcing, etc.)
• Supports Manufacturing and Service process creation (assembly/disassembly/rework), ensuring processes maintain design intent.
• Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
• Determines necessity of testing and initiates testing of assigned products
• Reports progress and status of assigned projects on a timely basis. 
• Regularly attends surgical observations (live surgery, wet labs, and/or dry labs) to gather input from end users and identify opportunities for product improvement.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Knowledge:

• Frequent use and general knowledge of industry practices, techniques, and standards.  General application of concepts and principles.
• Develops solutions to a variety of problems of moderate scope and complexity.  Refers to policies and practices for guidance.

Reasoning Ability:

• Develops solutions to a variety of problems of moderate scope and complexity.  Refers to policies and practices for guidance.
• Demonstrates a command of engineering skills through the ability to efficiently design intrinsically safe and effective solutions.
• Effectively communicates the motivation, theory, and practical trade-offs of designs and eagerly works with a multi-disciplinary team to realize the best overall solution.
• Has and maintains a healthy sense of risks and skepticism when developing design, plans, and test strategies.

Discretion/Latitude:

• Works under general supervision.
• Work is reviewed for soundness of judgment and overall adequacy and accuracy. 

Skills:

• Knowledge of FDA and ISO guidelines for the development of medical devices preferred.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of anatomy from an orthopedic standpoint preferred.
• Proficiency in designing products using a 3D-CAD program required (SolidWorks preferred).
• Demonstratable experience with latest ASME Y14.5 standards.
• Demonstratable experience with tolerance analysis (stack-up) methods.
• Technical knowledge in development methodologies, design, and project implementation preferred.
• Knowledge of orthopedic surgery principles, theories, products, and historical perspective preferred.
• Demonstratable experience with one or more design analysis tool (FEA, CFD, optical ray tracing, etc.) and appropriate methods to validate results.
• Demonstratable experience of Design for Quality tools such as FTA, FMEA, HALT/HASS.

Education/Experience:

• 2 Years of fu