Sr Engineer, Risk

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.

The research we do and the products we develop improve outcomes for patients around the world. As a Sr. Engineer, Risk at Vantive, your work supplies directly to making a significant impact on others. It's ambitious work-and you're not on your own. Our teams collaborate multi-functionally and lead by influence.

Job Responsibilities:

• Responsible for leading the activities associated with the Risk Management of products in various stages of the product lifecycle from new product development to post-market surveillance.
• Provides ongoing risk analysis and identification of required risk mitigations to ensure a safe, effective product.
• Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk
• Drive completion of Risk Management activities towards design transfer and successful commercialization of new products.
• Provides leadership and subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
• Creates and approves Design History File deliverables associated with Risk Management.
• Assesses and improves the Risk Management process.
• Facilitate an improved understanding of the interrelationship between Risk and Reliability.
• 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.
• Collaborates with Engineering, Manufacturing, and Service organizations in the development of design FMEA, Process FMEAs, and roll-up into Risk Management files. Working knowledge of FMEAs and standards applicable to Reliability Engineering (e.g. IEC 60812).
• Recognizes strategy, evaluates risks, recommends actions, and develops contingencies to address various scenarios. Able to analyze risk/tradeoffs and make recommendations of the appropriate path forward.
• Motivates and successfully influences stakeholders and cross-functional team members within the project.

Qualifications/Experience:

• BS/MS degree in Engineering, with approximately 7-10 years (5-7 years w/ MS) of practical Electromechanical Medical Device Design experience.
• Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project.
• Six Sigma Green belt or Black Belt (DFSS) certification preferred; LEAN certification preferred
• Must have a good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
• Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
• Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.).
• Membership and/or certification in a professional organization a plus (e.g. INCOSE).
• Experience working with Agile program methodologies
• Knowledge of Medical Device regulations (21CFR820, European MDD, Canadian Medical Device regulations, etc.).
• Understanding and application of the standards related to Risk Management and Reliability: (e.g., ISO 13485, ISO 14971, IEC 60812, IEC 61025, IEC 62366, IEC 60601, IEEE-1633, etc.)
• Experience developing requirements based on risk for products and/or process
• Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
• Experience leading collaboration and problem solving with globally located cross-functional representatives team members
• Experience in resolving complex technical problems using strong analytical skills

Vantive is committed to supporting the needs 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 $88,000- 121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than 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. 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.

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"), 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 | 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.

EEO is the Law
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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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