Software Validation Engineer #8289

ECI; Arden Hills (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player seeks a Software Validation Engineer to ensure the quality and compliance of software used in medical devices. This role involves developing validation strategies, executing testing protocols, and collaborating with cross-functional teams to maintain regulatory standards. The ideal candidate will have a strong background in the medical device industry, with expertise in validation processes and communication skills. Join a collaborative culture that values diverse perspectives and offers flexible employment options, making a significant impact on patient safety and regulatory compliance.

Qualifications

• 5+ years of experience in the medical device industry.
• Knowledge of V&V phases: test protocol development, execution, reporting.

Responsibilities

• Develop and implement software validation strategies aligned with regulatory requirements.
• Collaborate with software development and regulatory teams to integrate validation.

Skills

Software Validation

Regulatory Compliance

Test Protocol Development

Communication Skills

Education

Bachelor’s degree in Engineering

Tools

JTAG

Logic Analyzers

Oscilloscopes

Job description

Join to apply for the Software Validation Engineer #8289 role at ECI.

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients rely on our diverse perspectives and decades of expertise to address their toughest challenges. We pride ourselves on delivering transformative solutions with sustainable, long-term value. ECI has a proven track record in providing full product lifecycle consulting across various challenging projects. Our collaborative culture, welcoming team, and flexible employment and benefit options help us maintain strong relationships with talented professionals in the industry.

Role Overview

As a Software Validation Engineer, you will ensure the quality, reliability, and compliance of software used in medical devices. Your responsibilities will cover the entire software development lifecycle, focusing on validation processes to meet regulatory standards. You will collaborate with validation engineers and cross-functional teams to validate software applications critical to patient safety and regulatory compliance.

Key Responsibilities

1. Develop and implement software validation strategies aligned with regulatory requirements (FDA, ISO, etc.) and company standards.
2. Write, execute, and report manual testing protocols.
3. Create master validation plans for embedded software projects.
4. Provide technical guidance to team members for validation activities.
5. Stay updated on regulatory changes and ensure compliance of validation activities.
6. Work with regulatory teams to prepare documentation for submissions.
7. Integrate risk management into validation processes.
8. Maintain validation documentation, including plans, protocols, scripts, and reports.
9. Ensure documentation compliance with regulatory and quality standards.
10. Collaborate with software development, quality assurance, and regulatory teams to integrate validation into development.

Qualifications

1. Bachelor’s degree in Engineering or related field.
2. 5+ years of experience in the medical device industry.
3. Experience with medical device software development.
4. Knowledge of V&V phases: test protocol development, execution, reporting.
5. Understanding of circuit design, microcontrollers, microprocessors, FPGA.
6. Familiarity with communication protocols (SPI, CAN, UART, I2C).
7. Experience with debugging tools (JTAG, Logic Analyzers, oscilloscopes).
8. Knowledge of SDLC and Agile development processes.
9. Strong communication skills.

ECI is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic information, veteran status, marital or citizenship status, or any other protected status.

Candidates must be authorized to work in the U.S. without sponsorship now or in the future. ECI does not sponsor work visas for this role.