Software Design Assurance Engineer II
Company: Acist Medical Systems
Location: Eden Prairie
Posted on: November 21, 2022
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
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
- Ensure that specifications and requirements are relevant,
capable, contain essential elements and meet applicable standards,
and that all requirements are suitably testable and
- 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
- 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
Keywords: Acist Medical Systems, Eden Prairie , Software Design Assurance Engineer II, IT / Software / Systems , Eden Prairie, Minnesota
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