Principal Engineer, Quality

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.

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.

Summary
This role implements quality engineering functional activities to support Service System Support and Service Operations in the Product Development Lifecycle Management service-related activities, electromechanical medical device serviceability, service process continuous improvement and other quality system related activities.

Essential Duties and Responsibilities

Functional responsibilities of this position include:

• Serve as a core team member on product development activities.  Provide service quality input and direction to fulfill serviceability and compliance needs.

• Collaborate to implement service projects/changes for QMS compliance improvements.

• Provide quality approval support and impact analysis on change control records impacting Service to ensure completeness, accuracy, and continued product safety and effectiveness.  Own Service Quality tasks in the service-related change controls.

• Own and support NCR/CAPA records impacting service activities.

• Serve as Quality Approver for service-related documentation: Technical Service Bulletins, Service Document Listing, Service Instructions, Service Manuals, Checklists.

• Perform Service Quality Data analysis and present the results of analysis in quality review meetings as applicable (Product Quality Data Review, Management Review, etc).

• Act as Quality System Representative on computerized systems development and validation for Service System Support Engineering.

• Provide guidance and interact with Technical Service Center of Excellence, Service Quality Regional Leaders, and Operations to coordinate implementation of design and manufacturing changes.

• Support regulatory audits and inspections serving as a subject matter expert for Service Quality related topics.

• Provide value-added feedback for investigations and process changes to ensure safety and effectiveness of distributed devices, and customer satisfaction.

• Develop positive business relationships with key internal stakeholders (e.g., Technical Service, R&D, Regulatory Affairs etc) to implement Service Quality needs in compliance with regulatory and QMS requirements.

Requirements

• Working knowledge of medical device technologies, regulatory requirements, products and components.                                

• Working knowledge of quality engineering principles, risk management and continuous improvement techniques combined with lean business mindset and data driven decisions.

• Good soft skills and collaboration skills.

• Experience managing multiple projects of moderate complexity at the same time.

• Experience in structured problem solving and root cause analysis.

• Good communication and presentation skills.

• Appropriate written and verbal communication skills in English.  Technical writing experience preferred.

• Pragmatic and results-oriented: capable of prioritizing and planning activities with attention to understanding expectations of internal/external stakeholders.

Education and/or Experience:

• The function requires a bachelor’s degree in engineering, preferably in biomedical engineering.  Master’s degree preferred.

• Three to five years Quality / Service / R&D / Manufacturing or related experience in an electromechanical medical device regulated environment.

Thank you for your interest and application to Vantive. All applications will be reviewed and those candidates selected for consideration will be contacted directly.

Vantive is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.

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

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