Senior Staff Engineer, Design QA, Hardware & Embedded SW Systems (Remote / Flexible)

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Job Overview

The Senior Staff Engineer, Design QA, for Hardware & Embedded SW Systems at Insulet Corporation plays a pivotal role in ensuring the quality and reliability of innovative medical devices. This position involves leading design verification and validation efforts, collaborating with cross-functional teams to develop testing protocols, and implementing best practices in quality assurance. The candidate will be responsible for analyzing system performance, identifying possible design flaws, and providing comprehensive feedback to the engineering teams to drive continuous improvement in product quality.

Job Responsibilities

• Design and execute rigorous test plans for hardware and embedded software components.
• Lead cross-functional quality assurance initiatives throughout the product lifecycle.
• Develop and maintain quality metrics to evaluate both product performance and process effectiveness.
• Collaborate closely with hardware and software engineers to identify and resolve design issues.
• Facilitate design review meetings and contribute QA perspectives to the design process.
• Utilize root cause analysis techniques to address defects and implement corrective actions.
• Create documentation pertaining to quality assurance testing, processes, and outcomes.
• Stay updated with regulatory requirements and industry standards related to medical device quality assurance.

Qualifications

• Bachelor’s degree in Electrical Engineering, Computer Science, or similar engineering discipline; Master’s degree preferred.
• A minimum of 8 years of experience in hardware/software design verification and quality assurance.
• Strong knowledge of embedded systems, hardware components, and their interaction.
• Experience with regulatory requirements for medical devices, including ISO 13485 and FDA standards.
• Proficiency in testing frameworks, tools, and methodologies relevant to hardware and embedded systems.
• Exceptional analytical, problem-solving, and organizational skills.
• Excellent communication skills, with the ability to convey technical information effectively.

Technologies & Tools

The Senior Staff Engineer will utilize various technologies and tools essential for quality assurance and testing in hardware and embedded software systems. These include software development environments, debugging tools, automated testing frameworks, and performance analysis tools, as well as project management and documentation software to maintain robust quality records and progress reports.

Ideal Candidates

Ideal candidates for the Senior Staff Engineer position possess a robust technical foundation alongside a proactive and results-oriented mindset. They demonstrate strong leadership qualities and have a proven track record of working effectively in cross-functional teams. The ability to think critically and strategically, coupled with excellent communication skills, makes candidates well-suited for this role. A passion for innovation and commitment to improving product quality in the medical device industry are essential characteristics that will set candidates apart.