Sr. Principal Engineer, 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 dont 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.

Your Role:

In this role you will be responsible for Product Requirements management Traceability DHF structure & maintenance Product Risk management System integration verification and validation of medical devices. This position may own & perform relevant System Engineering activities for a family of devices in Acute therapies. Technically lead the team of system engineers towards realizing product development/enhancements over its lifecycle.

What youll be doing:

• Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance.

• Gathers inputs for Requirements from various sources such as User needs Regulatory Standards Quality Human factors Manufacturing Service and so on. Performs impact assessment on the requirements 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. Develop the recommended mitigation strategy with arationale.

• Expedite manage and coordinate interrelated systems 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 systems engineering.

• Facilitate an improved understanding of the interrelationship between Requirements Risk and Reliability.

• Working knowledge of FMEAs and standards applicable to Systems Engineering.

• Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.

• Understands clinical and user needs and can apply to product realization. Creates and maintains Design History File elements.

• Successfully influences stakeholders and cross-functional team members within the project.

• Teaches and mentors others in life cycle management methodologies.

• Initiates develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needs.

• Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope.

• Drives adherence to FDA ISO and IEC design control procedures regulations and standards.

• Anticipates technical challenges and risk scenarios and prepares leads and executes mitigation strategies to ensure optimal results.

• Can perform as an independent reviewer in technical and design reviews.

What youll bring:

• An engineering graduate in Electrical Mechanical Biomedical or related engineering discipline

• 12-18 years of experience required

• Prior experience in Medical/Acute device domain is a plus.

• Demonstrated ability to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/product

• Demonstrated broad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical Mechanical Software etc)

• A demonstrated track record in electromechanical system development preferably in medical devices or other highly regulated products such as military hardware.

• Effective communication skills both verbal and written

• Demonstrated strategic technical planner and thinker with ability to drive architecture/ platform/ technology deliverables into the product roadmap to ensure competitive differentiation.

Vantive is committed to supporting the need for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $120000 to $160000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

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US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical dental and vision coverage that start on day one as well as insurance coverage for basic life accident short-term and long-term disability and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (Aon PEP) Vantives 401(k) retirement savings plan to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options financial education and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts educational assistance programs and time-off benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Vantives US Benefits please speak with your recruiter or visit our Benefits site: Benefits Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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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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