Product Improvement Engineer (Santa Barbara, CA)
LaBine & Associates
- Santa Barbara, CA
Our medical device client is hiring a Product Improvement Engineer for their Santa Barbara location. This person is responsible for managing and coordinating Sustaining Electrical Engineering tasks including design, engineering, documentation, manufacturability and qualification of the project as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.
- Manage and coordinate as assigned Rapid Response Projects including the design, engineering, quotation, documentation, manufacturability and qualification of the project as required.
- Participate / lead regularly scheduled complaint review meetings, and provide statistical analysis of complaint trending.
- Provide timely corrective actions on all assigned defects and issues.
- Build prototypes, products and systems suitable for testing and may be required to set up and run lab simulations in order to perform root cause analysis.
- Initiate and execute Engineering Change Orders (including model / drawing changes and / or new model and drawing creation).
- Monitor corrective actions for effectiveness of implementation / solutions.
- 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 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.
- Supports Manufacturing to provide processing improvements.
- 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 to Engineering Manager.
- Maintain familiarity with Company technology, organization and business. Understand and provide technical solutions according to Arthrex strategy
- BS degree in Electrical Engineering/Physics/Bioengineering (with an emphasis EE) required.
- A minimum of 3 years experience is required in Electrical Engineering Product Improvement, Product Sustaining Electrical Engineering or Electrical Engineering Product Development at a commercial organization; medical device experience preferred.
- Working knowledge of anatomy from an orthopedic standpoint a plus.
- Working knowledge of electronic manufacturing practices
- Working knowledge of analog and digital circuit design, analysis, testing, troubleshooting.
- Knowledge of FDA and ISO guidelines for the development of medical devices.
- Project management and communication skills training preferred.
- Proficiency in designing products using an Electrical Engineering CAD program. Altium experience preferable.
- Manufacturing process knowledge preferred.
- Technical knowledge in development methodologies, design, and project implementation.
Thursday, September 12, 2019