About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

As a Software Validation Engineer, you will play a pivotal role in ensuring the quality, reliability, and compliance of software used in medical devices. Your responsibilities will encompass the entire software development lifecycle, focusing on validation processes to meet regulatory requirements and industry standards. You will be a member of a team of validation engineers, collaborating with cross-functional teams to guarantee the successful validation of software applications critical to patient safety and regulatory compliance.

What you'll do

Develop and implement comprehensive software validation strategies, ensuring alignment with regulatory requirements (FDA, ISO, etc.) and company standards.
Write, execute, and report out on manual testing protocols.
Create and execute master validation plans outlining the validation approach for each embedded software project.
Provide technical guidance and support to team members, ensuring the successful execution of validation activities.
Stay abreast of regulatory changes and ensure all software validation activities comply with current medical device regulations and industry standards.
Collaborate with regulatory affairs teams to provide documentation for regulatory submissions.
Ensure that risk management activities are integrated into the software validation process.
Oversee the creation and maintenance of validation documentation, including validation plans, protocols, test scripts, and reports.
Ensure that all documentation meets regulatory and quality system requirements.
Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure seamless integration of validation activities into the development process.

What you will bring

Bachelor’s degree required, preferably in Engineering
5+ years of experience in the medical device industry
Experience developing software in the medical device industry
Experience with all V&V phases: developing test protocols, executing protocols, report generation
Understanding of circuit design, microcontrollers, microprocessors, and FPGA's
Knowledge of communication protocols (SPI, CAN, UART, I2C)
Use of debugging tools including JTAG, Logic Analyzers, and oscilloscopes
General knowledge of SDLC and Agile software development process
Strong communication skills

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.

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Software Validation Engineer #8289

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