Senior Quality Assurance Lead for Hardware and Embedded Software Systems
17 hours ago
As a seasoned expert in Design Assurance and Quality Engineering, you will play a pivotal role in ensuring the development process is compliant with applicable standards, regulations, and guidance documents for medical devices containing Embedded Software.
Responsibilities:- You will be a key member of cross-functional development teams supporting development efforts for Hardware and Embedded Software Systems.
- Basic understanding of analog, digital, and mixed signal circuits including custom integrated circuits and simulation (Monte-Carlo, etc).
- Subject Matter Expert in Design Control to support the development organization. Provide oversight and support for the generation and approval of all Design History File deliverables.
- Subject Matter Expert for Risk Management Activities for complex systems in compliance with ISO14971.
- Subject Matter Expert ensuring compliance to the Software Development Life Cycle (IEC 62304) and FDA Guidance on Software Contained in a 510(k) Submission.
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
- Provide guidance to the development organization on the generation and review of requirements & specifications, design documents, design verification plans, protocols, and reports, traceability matrices and other documentation as required.
- Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities within the organization to align with industry best practices.
To excel in this role, you should have a BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or Science degree, along with a minimum of 8 years of work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment.
The estimated salary range for this position is $99,600.00 - $149,700.00, reflecting the base salary only. This figure may vary based on location and individual factors such as job-related skills, experience, and relevant education or training.
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