Vantive
Overview
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams. For 70 years, we have driven innovations in kidney care and are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while investing in transforming vital organ therapies. We seek to deliver greater flexibility and efficiency in therapy administration for care teams and longer, fuller lives for patients. Join a community of focused, courageous people who help improve patients’ lives worldwide. We strive for meaningful work and a mission to extend lives and expand possibilities. Responsibilities
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). 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). Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings. Develop and execute test method validations, product testing, and verification/validation activities. Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. What You’ll Bring (Qualifications)
Bachelor degree in mechanical, plastics, biomedical engineering, or a related field; Master’s degree preferred. 3+ years of related experience in Class II or Class III disposable medical product development. Design for Six Sigma (DFSS) training or certification preferred. Working knowledge of plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization). Working knowledge of CAD design and PDM enterprise software (e.g., Creo, SolidWorks). Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. US Benefits At Vantive
Vantive offers comprehensive compensation and benefits packages for eligible roles. Health and well-being benefits include medical, dental, and vision coverage starting 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) and a 401(k) retirement savings plan. The plan provides retirement resources, investment options, financial education, and resources to support retirement goals. We also offer Flexible Spending Accounts, educational assistance programs, and paid time off, including holidays, paid time off (20–35 days based on service), family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, employee discount programs, an Employee Assistance Program (EAP), and childcare benefits. Speak with your recruiter or visit our Benefits site for more information. Equal Employment Opportunity
Vantive is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic. Reasonable Accommodation
Vantive is committed to providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please contact us with your request and contact information. Recruitment Fraud Notice
Vantive has identified incidents of employment scams where fraudulent parties pose as Vantive employees or recruiters. To learn how to protect yourself, review our Recruitment Fraud Notice.
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Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams. For 70 years, we have driven innovations in kidney care and are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while investing in transforming vital organ therapies. We seek to deliver greater flexibility and efficiency in therapy administration for care teams and longer, fuller lives for patients. Join a community of focused, courageous people who help improve patients’ lives worldwide. We strive for meaningful work and a mission to extend lives and expand possibilities. Responsibilities
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). 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). Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings. Develop and execute test method validations, product testing, and verification/validation activities. Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment. Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance. What You’ll Bring (Qualifications)
Bachelor degree in mechanical, plastics, biomedical engineering, or a related field; Master’s degree preferred. 3+ years of related experience in Class II or Class III disposable medical product development. Design for Six Sigma (DFSS) training or certification preferred. Working knowledge of plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization). Working knowledge of CAD design and PDM enterprise software (e.g., Creo, SolidWorks). Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. US Benefits At Vantive
Vantive offers comprehensive compensation and benefits packages for eligible roles. Health and well-being benefits include medical, dental, and vision coverage starting 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) and a 401(k) retirement savings plan. The plan provides retirement resources, investment options, financial education, and resources to support retirement goals. We also offer Flexible Spending Accounts, educational assistance programs, and paid time off, including holidays, paid time off (20–35 days based on service), family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, employee discount programs, an Employee Assistance Program (EAP), and childcare benefits. Speak with your recruiter or visit our Benefits site for more information. Equal Employment Opportunity
Vantive is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic. Reasonable Accommodation
Vantive is committed to providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please contact us with your request and contact information. Recruitment Fraud Notice
Vantive has identified incidents of employment scams where fraudulent parties pose as Vantive employees or recruiters. To learn how to protect yourself, review our Recruitment Fraud Notice.
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