Sr 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.Your RoleIn the Senior Principal Engineer, Systems 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 You'll Be DoingPerform 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 surveillanceGather inputs for Requirements from various sources such as, User needs, Regulatory Standards, Quality, Human factors, Manufacturing, Service, and so on. Perform 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 a rationale.Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing prioritiesParticipate in identifying and planning tasks, activities, and resourcing needs related to systems engineeringFacilitate an improved understanding of the interrelationship between Requirements, Risk, and ReliabilityWorking knowledge of FMEAs and standards applicable to Systems EngineeringCreate design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain areaUnderstand clinical and user needs and can apply to product realization. Create and maintains Design History File elements.Influence stakeholders and cross-functional team members within the projectTeach and mentor others in life cycle management methodologiesInitiates, develops and leads technical feasibility analysis for products or subsystems; translates customer/user needs to product needsPropose and drive solutions to complex technical problems that are ambiguous and diverse in scopeDrive adherence to FDA, ISO and IEC design control procedures, regulations and standardsAnticipate technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal resultsPerform as an independent reviewer in technical and design reviewsRequired SkillsA Bachelor's Degree in Electrical, Mechanical, Biomedical, or a related engineering or science discipline12 years or more of relevant experienceBroad exposure to HW/SW/Systems design and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc.)Preferred SkillsPrior experience in Medical/Acute device domainAbility to work with technical leadership team to implement product platform/subsystem multi-generation technology plan for a specific release of a global program/productA track record in electromechanical system development, preferably in medical devices or other highly regulated products such as military hardwareEffective communication skills, both verbal and writtenDemonstrated strategic technical planning and thinking with ability to drive architecture/ platform/ technology deliverables into the product roadmap to ensure competitive differentiationVantive 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 $120,000 to $165,000 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.Advanced Molding and Extrusion techniques (Learning / Doing (1)), Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Bar coding, Printing, & Label Specifications (Applying / Overseeing (2)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), In-depth Understanding of Operational Systems (Applying / Overseeing (2)), Instrumentation (Leading / Driving (4)), Laboratory Maintenance & Material Tracking (Not Applicable (0)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Manufacturing Process Knowledge (Leading / Driving (4)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Packaging Assessments (Applying / Overseeing (2)), Packaging Design (Applying / Overseeing (2)), Packaging Regulatory Standards & Requirements (Applying / Overseeing (2)), Packaging Validation (Applying / Overseeing (2)), Packaging Verification Study Development & Testing Standards (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Product & Medical Packaging Materials / Equipment Knowledge (Applying / Overseeing (2)) {+ 8 more}US Benefits At VantiveThis 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”), Vantive’s 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 employees. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | VantiveEqual Employment OpportunityVantive 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.Know Your Rights: Workplace Discrimination is IllegalReasonable AccommodationVantive 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 LinkRecruitment Fraud NoticeVantive 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.