Lead Systems/Software Verification Test Engineer

Concord, CA

Posted: 09/15/2020 Employment Type: Direct Hire Category: QA Tester Job Number: 54539

Job Description


Responsibilities
  • Compose reports and make adjustments to equipment or processes that require improvement
  • Responsible for assuring projects meet customer expectations, and regulatory requirements
  • Provide guidance to engineering staff and other personnel and ensure that design control requirements and being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review
  • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures
  • Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards
  • Assist in the development and maintenance of company procedures for design control, change management, risk management, test method validation, process validation and related areas of the quality management system
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices
  • Perform white box testing on medical device systems.

Requirements
  • Bachelor’ s or Master’ s in Computer Science, Software Engineering, Biomedical Engineering or related field required
  • MUST have experience with medical device testing (dialysis experience highly preferred)
  • MUST have experience with systems level testing
  • MUST have experience with white/black box testing
  • Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements
  • Ability to multi-task and operate within a fast-paced environment
  • Excellent oral, written, analytical, computer and interpersonal skills
  • Functional Testing Experience
  • Proactive Individual who is self-motivated and confident

 
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