Software Design Assurance Engineer II

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.

Required Skills

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by ACIST Medical Systems
• B.S. in Engineering, Computer Science, Information Systems, or similar discipline
• 3 - 5 years of experience in Product software applications, developer, analyst and/or QA
• 3+ years of experience with software validation in a medical device environment
• Experience with software development methodologies
• Working knowledge of the FDA Quality System Regulation, ISO 13485, the Medical Device Directive and Medical Device Regulations
• Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems
• Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.
• Demonstrated knowledge and proficiency in quality principles and best practices
• Strong collaboration skills to effectively communicate with both business and technical teams
• Effective oral and written communication skills
• Effective technical writing skills
• Ability to work independently
• Ability to travel both domestically and internationally

Preferred:

• Advanced degree in Computer Science, Software Engineering, or similar discipline
• ASQ CSQE (Certified Software Quality Engineer) or similar certification
• Experience with Agile PLM, Jama, TrackWise and/or SAP
• Demonstrated project management skills
• Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software
• Experience with cybersecurity and knowledgeable in HIPAA regulations and GDPR and related data protection policies

Other:

• Travel expected to be less than 15%.