Principal Software Quality Engineer

Overview

On Site

BASED ON EXPERIENCE

Contract - W2

Contract - Independent

Contract - 12+ mo(s)

Skills

QSR

MEDICAL DEVICE

COMPUTER SCIENCE

ENGINEERING

IEC 62304

IEC 82304-1

Job Details

Primary Talent Partners has an open 12 month W2 contract with a large medical device client of ours in the Mounds View, MN area.
Pay Range: $80.00 to $90.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to)

Position Overview

This role involves a leadership position in software quality engineering, focusing on driving quality into software solutions for cardiac imaging and transcatheter heart valve implantation applications. The candidate will work within the software development lifecycle, ensuring compliance with global regulatory standards.

Key Responsibilities

Lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation), and other global regulatory agencies requirements.
Lead quality-focused design and development of software by defining requirements, design, verification, and validation plans and strategies while maintaining traceability.
Develop test strategies, review test designs, and validate test scripts for the Transcatheter Valve Implant Sizing application, including cybersecurity requirements.
Develop, document, and test software to ensure it meets end-user needs and achieves business goals.
Develop and validate software-related scripts using Python / MATLAB for Finite Element Analysis, clinical imaging, Structural Integrity (Fatigue) testing, and other design modeling applications.
Lead and conduct risk management activities, including system risk analysis (ISO14971) and software risk management documentation.
Provide Software (SW) risk management technical leadership to Design Quality Engineering peers.
Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/IEC82304-1/HIPAA/FDA/Security Standards/Cybersecurity/Data Privacy).
Participate in design reviews for the system and review and approve design input/output artifacts including requirements, design documents, code review reports, test results, verification, and validation reports.
Review software systems design, change specifications, and plans against contractual and/or process requirements.
Provide guidance, coaching, and training to other employees within the job area.

Required Knowledge and Experience

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management.

Requires a Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering, or a technical field. Minimum of 7 years of technical experience, or an advanced degree with 5 years of technical experience.

Preferred Qualifications

Mastery of the SiMD and SaMD regulatory landscape.
Experience with cardiac imaging data analysis.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
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