Principal Engineering Compliance

Responsibilities

• Lead and coordinate standards compliance activities for assigned medical device product programs.
• Partner with design and development engineers to define product requirements for safety, EMC, and alarm standards.
• Develop and execute comprehensive compliance plans aligned with IEC 60601-1, -1-2, and -1-8.
• Drive global product certification strategies to enable timely market access across international regions.
• Manage compliance issues throughout the full product lifecycle, including design changes and post-market updates.
• Coordinate product testing at internal facilities and external accredited laboratories.
• Oversee wireless host testing for products incorporating wireless technologies.
• Prepare, review, and approve technical test reports and documentation for regulatory submissions.

Requirements

• Bachelor's or Master's degree in Engineering.
• Minimum 15+ years of experience in compliance engineering or a related discipline.
• In-depth knowledge of global medical device regulatory and standards requirements (US, EU, Canada, Australia, Japan, Brazil, and China).
• Strong expertise with the IEC 60601-1 family of standards.
• Excellent understanding of EMC and wireless test equipment, test methods, and compliance evaluation.
• Proven ability to diagnose and resolve EMC and wireless compliance failures.
• Experience working with regulatory authorities and conformity assessment bodies (e.g., UL, Intertek, TÜV).

Preferred Qualifications

• Strong electronics engineering background.
• Experience with wireless regulations and wireless certification procedures.
• Knowledge of FDA design control requirements and software lifecycle standards (e.g., IEC 62304).
• Proficiency with requirements management, configuration management, and traceability systems.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care, and we are now deepening our commitment to elevating the dialysis experience through digital solutions and advanced services.