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Title: Engineer - Product Improvement

Location: Santa Barbara, CA

MAIN OBJECTIVE:

Manage and coordinate as assigned Sustaining Engineering tasks including design, engineering,
documentation, manufacturability and qualification of the project as required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Designs components or functional systems, and modifies existing designs to develop or improve
products and facilitate manufacturing operations.
2. Manage and coordinate as assigned Rapid Response Projects including the design, engineering,
quotation, documentation, manufacturability and qualification of the project as required.
3. Participate / lead regularly scheduled complaint review meetings, and provide statistical
analysis of complaint trending.
4. Provide timely corrective actions on all assigned defects and issues.
5. Build prototypes, products and systems suitable for testing and may be required to set up and
run lab simulations to perform root cause analysis.
6. Initiate and execute Engineering Change Orders (including model / drawing changes and / or
new model and drawing creation).
7. Monitor corrective actions for effectiveness of implementation / solutions.
8. Recommends alterations to development and design to improve quality of products and/or
procedures.
9. Determines budgets and timelines for assigned projects.
10. Maintains design history file for assigned projects, adhering to design control procedures.
11. Provides Regulatory department technical support for assigned projects as needed.
12. Supports Marketing and Product Management with technical information to be used for training
and marketing of assigned products.
13. Supports Manufacturing to provide processing improvements.
14. Supports surgeon and distributor customers by training and/or educating on technical aspects
of assigned products as needed.
15. Determines necessity of testing and initiates testing of assigned products
16. Reports progress and status of assigned projects on a timely basis to Engineering Manager.
17. Maintain familiarity with Company technology, organization and business. Understand and
provide technical solutions according to strategy.

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:

BS degree in Mechanical / Bioengineering required.

A minimum of 3 years of relevant medical device experience is required.

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

● Working knowledge of anatomy from an orthopedic standpoint.


● Working knowledge of manufacturing practices.

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

● Project management and communication skills training preferred.

Machine, Tools, and/or Equipment Skills:

 Proficiency in designing products using a 3D-CAD program. Pro/E and/or SolidWorks experience
preferable.
 Manufacturing process knowledge preferred.
 Technical knowledge in development methodologies, design, and project implementation.

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