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:
We are seeking a skilled engineer with strong experience in medical device safety and regulatory compliance, particularly in electrical and active implantable systems. The role focuses on ensuring products meet international safety and performance standards such as EN 60601-1, EN 60601-1-2, EN 60601-1-11, ISO 14708-1, and ISO 14708-3.
What You'll Do
- Ensure product compliance with:
- EN 60601-1 (basic safety & essential performance)
- EN 60601-1-2 (electromagnetic compatibility)
- EN 60601-1-11 (home-use devices)
- ISO 14708-1 (implantable device safety)
- ISO 14708-3 (neurostimulators)
- Interpret and apply regulatory requirements throughout the product lifecycle.
- Collaborate with R&D teams to design compliant medical electrical and implantable devices.
- Define essential performance and safety requirements early in development.
- Support system architecture decisions to meet electrical safety and EMC requirements.
- Plan and oversee; Electrical safety testing (leakage current, insulation, et, EMC testing, immunity & emissions, and environmental and home-use condition testing
- Work with external test labs and certification bodies.
- Review and approve test reports for regulatory submissions.
- Perform risk analysis aligned with ISO 14971 principles.
- Develop and maintain, technical files / design dossiers, test plans and reports, labeling and Instructions for Use (IFU)
- Ensure traceability between risks, requirements, and verification.
What We Look For
- 3–8+ years in medical device development or compliance
- Hands-on experience with EN 60601-1 testing and documentation and EMC requirements per EN 60601-1-2
- Experience with implantable devices and ISO 14708-1 preferred
- Strong understanding of medical electrical safety principles
- Knowledge of EMC design and mitigation techniques
- Familiarity with implantable device constraints (power, biocompatibility, reliability)
- Excellent documentation and technical writing skills
- Ability to work cross-functionally with engineering and regulatory teams