Sr Principal Engineer, Systems

Responsibilities

• Perform systems engineering activities for products throughout the entire lifecycle, from new development to post-market surveillance.
• Gather and manage requirements from diverse sources including user needs, regulatory standards, quality, and manufacturing.
• Conduct impact assessments for design, material, or process changes to determine necessary mitigations.
• Manage and coordinate interrelated systems activities across cross-functional teams.
• Facilitate understanding of the relationships between requirements, risk, and reliability.
• Create design concepts and research methodologies to meet customer and business needs.
• Maintain Design History File (DHF) elements and ensure adherence to FDA, ISO, and IEC design control procedures.
• Lead technical feasibility analyses and translate user needs into actionable product requirements.
• Mentor and teach others in life cycle management methodologies.

Requirements

• Engineering degree in Electrical, Mechanical, Biomedical, or a related discipline.
• 12-18 years of professional engineering experience.
• Proven experience in the Medical or Acute device domain.
• Broad exposure to HW/SW/Systems design with technical depth in at least one engineering discipline.
• Demonstrated track record in electromechanical system development within highly regulated environments.
• Working knowledge of FMEAs and applicable ISO/IEC standards.
• Strong strategic technical planning skills and ability to drive architecture into product roadmaps.
• Excellent verbal and written communication skills.

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. With a 70-year legacy of innovation in kidney care, Vantive is expanding its commitment to elevating the dialysis experience through digital solutions and advanced services, while investing in the future of transforming vital organ therapies.