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. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job Summary

The Senior Principal Engineer, Compliance is responsible for leading and coordinating standards compliance activities for assigned product programs. This role partners closely with cross‑functional product development teams to identify applicable regulatory and standards requirements, develop and execute compliance plans, coordinate internal and external testing, review compliance evidence, and work with certification bodies to achieve and maintain product certifications across global markets throughout the product lifecycle.

Essential Duties and Responsibilities

The incumbent will perform the following primary responsibilities, along with other duties as assigned.

1. Product Requirements and Compliance Planning

• Partner with design and development engineers to define product requirements ensuring compliance with applicable medical device safety, EMC, and alarm standards, including IEC 60601‑1 (General Safety), IEC 60601‑1‑2 (EMC), IEC 60601‑1‑8 (Alarm Systems), and applicable IEC 60601‑2 particular standards relevant to medical renal dialysis systems.

• Develop, maintain, and execute Compliance Plans aligned with IEC 60601‑1, ‑1‑2, ‑1‑8, and renal dialysis–specific safety and performance standards for intended global markets.

• Participate in design and development activities to identify, assess, and resolve product safety, EMC, alarm, and certification issues, including those specific to renal dialysis therapies and extracorporeal blood treatment systems.

2. Product Certification Strategy and Lifecycle Compliance

• Develop and drive global product certification strategies supporting compliance with IEC 60601‑1, IEC 60601‑1‑2, IEC 60601‑1‑8, and applicable IEC 60601‑2 particular standards for renal dialysis medical devices, enabling timely market access.

• Lead and manage safety, EMC, alarm system, and therapy‑specific compliance issues throughout the full product lifecycle, including design changes and post‑market updates.

• Support compliance with environmental regulations (e.g., RoHS, REACH, WEEE) in partnership with the Environmental Health and Safety (EHS) team.

3. Cross‑Functional Compliance Strategy and Roadmaps

• Coordinate input from cross‑functional stakeholders to define and execute comprehensive compliance strategies covering general safety, EMC, alarm systems, wireless, and renal dialysis‑specific regulatory and standards requirements.

• Develop and maintain therapy‑area compliance roadmaps and dashboards, including renal dialysis product families, tracking certification status, gaps, and remediation actions.

4. Regulatory Compliance and Testing Oversight

• Maintain current knowledge of changes to medical device safety, EMC, and alarm standards, including IEC 60601‑1, IEC 60601‑1‑2, IEC 60601‑1‑8, as well as IEC 60601‑2 particular standards and other international standards applicable to medical renal dialysis devices (e.g., dialysis systems, accessories, and fluids).

• Ensure in‑house compliance test equipment and test methods meet the requirements of safety, EMC, and alarm system standards, including those applicable to renal dialysis therapies.

• Plan, schedule, and coordinate product safety, EMC, alarm system, and therapy‑specific compliance testing at internal test facilities and external accredited laboratories.

5. Wireless Testing and Regulatory Submissions

• Manage and plan wireless host testing for products incorporating wireless technologies, ensuring alignment with IEC 60601‑1‑2, IEC 60601‑1‑8 (where alarms are impacted), and applicable wireless regulations.

• Support global regulatory submissions and approvals (e.g., EU, UL, Canada, Korea, Japan, Australia), including renal dialysis‑specific safety, EMC, alarm, and therapy compliance documentation.

6. Documentation and Technical Communication

• Prepare, review, and approve safety, EMC, and alarm system test reports in accordance with IEC 60601‑1, IEC 60601‑1‑2, IEC 60601‑1‑8, and applicable renal dialysis standards.

• Provide technical direction and clear communication across engineering, quality, regulatory, clinical, and legal teams to ensure consistent understanding and execution of renal dialysis compliance obligations.

Qualifications

To perform this role successfully, the individual must demonstrate the following knowledge, skills, and abilities:

• In‑depth knowledge of global medical device regulatory and standards requirements, with strong understanding of U.S., European Union, Canada, Australia, Japan, Brazil, and China markets.

• Strong experience with the IEC 60601‑1 family of standards; experience with wireless regulations preferred.

• Excellent understanding of EMC and wireless test equipment, test methods, and compliance evaluation per international and domestic standards.

• Knowledge of EMC and wireless certification requirements and procedures for medical devices worldwide, including standards such as IEC 60601‑1‑2, CISPR 11, FCC, and RED.

• Demonstrated ability to diagnose and resolve EMC and wireless compliance failures in collaboration with design engineering teams.

• Strong electronics engineering background preferred.

• Experience with requirements management, configuration management, defect tracking, and traceability systems.

• Familiarity with EMC design tools, EMC testing tools, and electronic test equipment.

• Knowledge of national and international product safety standards.

• Strong written, verbal, and interpersonal communication skills.

• Proven ability to manage multiple priorities, timelines, and deliverables effectively.

• Knowledge of FDA design control requirements and software lifecycle standards (e.g., IEC 62304), as well as relevant ANSI/IEEE standards.

• Demonstrated experience working with regulatory authorities, conformity assessment bodies (e.g., UL, Intertek, TÜV, CSA), and standards development organizations (e.g., IEC, ISO, ETSI, NFPA).

Education and Experience

• Bachelor’s or Master’s degree in Engineering required.

• Minimum 15+ years of experience in compliance engineering or a related discipline.

• Demonstrated understanding of engineering theories and practices beyond primary area of expertise.

• Strong working knowledge of international design safety and compliance standards.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.