Qureos Mentor

Vantive

<div>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&mdash; 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&rsquo;t settle for the mediocre. Each of us is driven to help improve patients&rsquo; lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.
Job Title:
Sr. Engineer &ndash; Disposables R&amp;D
Job Profile:
Prof II- Engineering &ndash; General Engineering
Group - Family:
Engineering &ndash; General Engineering
FLSA:
Exempt
Grade:
16
Summary:
This section focuses on the main purpose of the job in one to four sentences.
Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices.
Essential Duties and Responsibilities:
This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.<ul><li>Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes and product development (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).</li><li>Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).</li><li>Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.</li><li>Develop and execute test method validations, product testing, and verification / validation activities.</li><li>Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.</li><li>Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.</li></ul>
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.<ul><li>Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.</li><li>Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks).</li><li>Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.</li><li>Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.</li><li>Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.</li><li>Strong collaboration, verbal and written communication skills.</li><li>Strong attention to detail, organized, and able to independently manage multiple priorities.</li><li>Ability to read, write and comprehend English.</li></ul> 
Experience and/or Background
BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.<ul><li>3 - 5 years of related experience in Class II or Class III disposables medical product development.</li><li>Design for Six Sigma (DFSS) training or certification preferred.</li></ul>
Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability &amp; smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis &amp; Analytics (Applying / Overseeing (2)), Digitalization &amp; Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean &amp; six sigma process knowledge (Applying / Overseeing (2)), Machine Learning &amp; Artificial Intelligence (Not Applicable (0)), Manufacturing &amp; Process Knowledge (Applying / Overseeing (2)), Modeling &amp; Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))
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 (&ldquo;Aon PEP&rdquo;), Vantive&rsquo;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&rsquo;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. 
 
Know Your Rights: Workplace Discrimination is Illegal
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
Recruitment Fraud Notice 
 
Vantive 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.</div>

Sr Engineer

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Vantive

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Sr Engineer