- Write design verification test plans
- Write test procedures for the purposes of design verification
- Run test procedures written by self and others.
- Report test results to project leads.
- Track issues found during testing.
- Provide input on the design of electrical, optical, and mechanical test fixtures
- Review product specifications in order to ensure they are comprehensive and testable
- With Project Engineers, devise and execute tests to assist in resolving design issues as they relate to product quality, manufacturability, reliability, efficacy, and regulatory compliance.
- Assist with troubleshooting of product returns and issues found in the field, and recommend test procedures to verify the resolution of field issues and returns.
- Train other test engineers on test procedures and DQA protocols
- Assist Manager/Sr. Test Engineers in the evaluation of test equipment required to perform quality checks
- Performs other related duties as assigned by supervisor
- Must have strong analytical skills and good technical report writing skills.
- Must have good interpersonal and communication skills, both verbal and written.
- Familiarity with Environmental testing and equipment.
- Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001)
- B.S. degree in Electronics Technology/Engineering or related field with 3-5 years experience in technical and test engineering
- MS degree in Electronics Technology/Engineering or related field with 0-3 years experience in technical and test engineering
- Manual dexterity to work with small parts.
- Good eyesight and hand to eye coordination.
- Cannot be colorblind.
- Ability to lift up to 30 pounds.
- Injury and Illness Prevention Program; annually - OSHA requirement
- Quality System training
- Job Specific - In house requirement
- Work with Engineering staff, Manufacturing Engineers and staff, and Engineering Technical Services Manager - to request and provide information or services; to advise and solve technical problems.
- Call or meet with Vendors/Application Engineers.
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Test Engineer II - Goleta, United States - KARL STORZ Endoscopy - America
Description
Job Description
JOB SUMMARY:
Brief description of what this person does, in simple direct terms
Under minimal supervision, provides design verification support for Karl Storz products to verify that they meet quality standards, including the design and execution of approved verification procedures, the execution of studies and troubleshooting in support of design engineering, and the training of other test engineers.
ESSENTIAL FUNCTIONS:
List the essential duties and responsibilities of the position, in order of importance and/or amount of time spent.
Design Verification Functions
ADDITIONAL RESPONSIBILITES:
List other important functions that are secondary duties but may be time consuming.
ABILITIES:
What does a person in this position need to be able to do?
Desired:
Familiarity with high level programming language/software such as Matlab, Lab View, or similar to assist in developing automated testing and data collection.
EDUCATION AND EXPERIENCE:
What is the usual educational background and work experience of an individual qualified to perform this job?
MENTAL REQUIREMENTS:
What are the specific physical and mental demands of this position?
TRAINING REQUIREMENTS:
Safety, regulatory compliance, legal & job specific
LEVEL OF SUPERVISION REQUIRED:
How closely is this position supervised day to day?
Minimal Level of supervision
INTERFACE:
(Internal/External Customers) List positions, work groups, departments.
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