Senior Software Design Assurance Engineer-Medical Device  #7809

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 with 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

The Senior Software Design Assurance (Sr Software Design Quality) Engineer provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulations and standards (e.g. IEC 62304, ISO 13485, ISO 14971).

What you will do

This role will be responsible for various aspects of Software Design Assurance with a focus on product improvement, new product development, and defect prevention. This position will interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering, Cybersecurity, and others). A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities. This is NOT a software test role.

What you will bring

• Bachelor’s degree in computer science, software engineering, electrical engineering, or related discipline with 5+ years of medical device industry experience, or a Master’s degree with 3+ years of experience
  Solid experience in software design assurance for software used in a regulated environment such as SaMD and SiMD
  • Demonstrate hands on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485
  • Proficiency includes applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification
  • Proven experience performing and reviewing software risk management activities, including Software Hazard Analysis (SHA), design FMEA, and change impact assessments
  • Skilled at reviewing and approving software design control deliverables to ensure traceability, risk control implementation, and regulatory compliance
  • Hands-on experience supporting software configuration management, and tool validation
  • Communicate effectively with cross functional partners and can clearly present design assurance, risk, and compliance topics to technical teams and senior leadership
  • Proven track record in applying medical device regulations and standards to software projects
  • Experience in leading design assurance activities, risk management, verification, and validation throughout the product lifecycle
  • Participation in new product development and sustaining product projects, ensuring clear scope and objectives are met
  • Involvement in regulatory inspections and remediation initiatives
  • Knowledge of regulatory and safety challenges for AI/ML in medical devices

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.