Principal Eng, Systems

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.

This position owns & performs the System Requirements and Risk management activities for either a new product under development or a family of dialysis devices as they are used in dialysis therapy, in accordance with the regulatory standards (main being ISO 14971) & requirements.
- As a member of cross-functional team, integrates cross functional inputs to delivery of a project of minor to moderate complexity
- Responsible for performing the activities associated with the System Requirements and Risk Management of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
- Understands the user needs, derives the system requirements, authors the same, reviews with cross functional teams and maintains the same for any changes and traceability. Flows down the same to sub system requirements working with sub system teams.
- Performs risk assessment on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation.
- Come-up with the recommended mitigation with the rationale.
- Ensure that no unacceptable risk goes undetected and unmitigated.
- Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.
- Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
- Facilitate an improved understanding of the interrelationship between Risk and Reliability.
- Working knowledge of FMEAs and standards applicable to Reliability Engineering.
- Leads Risk Management activities in coordination with other cross-functions like HW, SW, HF,
- Collaborates with Engineering, Manufacturing and Service organizations in the development of design FMEA, Process FMEAs and roll-up into Risk Management files.
- Creates and approves Design History File deliverables associated with Risk Management.
- Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product.
- Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
- Successfully influences stakeholders and cross-functional team members within the project.

**Education, Experience & key attributes**:

- Graduate degree in Engineering, with minimum 8 years of practical Electromechanical Medical Device Design experience, some of which is in Requirement and Risk management.
- Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project.
- Sound knowledge identifying, authoring system requirements derived from user needs
- Good understanding of medical device QMS ISO 13485 with experience of having worked in this environment.
- Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
- Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.)
- Requires a high level of independence and excellent interpersonal and communication skills.
- Able to prepare and make written and verbal presentations to cross-functional audiences as required.
- Team player
- Six Sigma Green belt or Black Belt (DFSS) certification preferred.

**Reasonable Accommodation**

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