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Test Engineer II
3 months ago
• 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 Design Engineering Support Functions
• 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. Training Function
• Train other test engineers on test procedures and DQA protocols ADDITIONAL RESPONSIBILITES: List other important functions that are secondary duties but may be time consuming.
• Assist Manager/Sr. Test Engineers in the evaluation of test equipment required to perform quality checks
• Performs other related duties as assigned by supervisor KNOWLEDGE, SKILLS, ABILITIES: What does a person in this position need to be able to do?
• 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.
• Desired: Familiarity with high level programming language/software such as Matlab, Lab View, or similar to assist in developing automated testing and data collection.
• Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job?
• 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 PHYSICAL & MENTAL REQUIREMENTS: What are the specific physical and mental demands of this position?
• Manual dexterity to work with small parts.
• Good eyesight and hand to eye coordination.
• Cannot be colorblind.
• Ability to lift up to 30 pounds. TRAINING REQUIREMENTS: Safety, regulatory compliance, legal & job specific
• Injury and Illness Prevention Program; annually - OSHA requirement
• Quality System training
• Job Specific - In house requirement 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.
• 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. Get in Contact