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Software Design Assurance Engineer II

Company: Acist Medical Systems
Location: Eden Prairie
Posted on: November 21, 2022

Job Description:

Position Summary:
The Software Design Assurance Engineer II position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for Design Verification and Validation activities while ensuring compliance to BMT design control procedures and applicable regulations and external standards.
Primary Duties & Responsibilities:
Design Assurance - Software

  • Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to software, electrical, mechanical, and consumable products.
  • Drive the Design Control process and own the Design History File (DHF) within the framework of regulatory requirements.
  • Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
  • Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
  • Lead risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
  • Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Generate the QA deliverables to meet the project scope and plan.
  • Review, provide input, and approve project-related deliverables and change orders.
  • Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.

Keywords: Acist Medical Systems, Eden Prairie , Software Design Assurance Engineer II, IT / Software / Systems , Eden Prairie, Minnesota

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