Vantive
Engineer I – Disposables R&D, Sustaining
Vantive, Minneapolis, Minnesota, United States, 55447
Job Description
Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams worldwide. For 70 years our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while investing in transforming vital organ therapies. Your Role
Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices. What You’ll Be Doing
Support R&D projects 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. Support and execute test method validations, product testing, and verification/validation activities. Build prototypes and models. 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
BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred. 1+ years of related experience in Class II or Class III disposables medical product development. Design for Six Sigma (DFSS) training or certification preferred. Understanding of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization. Working knowledge of CAD design and PDM enterprise software (e.g., Creo, Solidworks). Understanding of FDA Design Controls and ISO 13485 Quality Management Systems. Understanding of ANSI/AAMI/ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. Initiative with a high aptitude for learning, innovation, and continuous improvement. Compensation
Estimated base salary for this position is $78,000 – $108,000 annually. The range reflects anticipated salary and may vary based on market data and other factors. Benefits
Vantive offers comprehensive compensation and benefits packages including medical, dental, vision, life, short‑term, and long‑term disability, business travel accident insurance, 401(k) retirement savings plan, flexible spending accounts, educational assistance programs, paid holidays, paid time off, family and medical leaves, paid parental leave, commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits. 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. Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. 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 to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
#J-18808-Ljbffr
Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams worldwide. For 70 years our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while investing in transforming vital organ therapies. Your Role
Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices. What You’ll Be Doing
Support R&D projects 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. Support and execute test method validations, product testing, and verification/validation activities. Build prototypes and models. 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
BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred. 1+ years of related experience in Class II or Class III disposables medical product development. Design for Six Sigma (DFSS) training or certification preferred. Understanding of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization. Working knowledge of CAD design and PDM enterprise software (e.g., Creo, Solidworks). Understanding of FDA Design Controls and ISO 13485 Quality Management Systems. Understanding of ANSI/AAMI/ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. Initiative with a high aptitude for learning, innovation, and continuous improvement. Compensation
Estimated base salary for this position is $78,000 – $108,000 annually. The range reflects anticipated salary and may vary based on market data and other factors. Benefits
Vantive offers comprehensive compensation and benefits packages including medical, dental, vision, life, short‑term, and long‑term disability, business travel accident insurance, 401(k) retirement savings plan, flexible spending accounts, educational assistance programs, paid holidays, paid time off, family and medical leaves, paid parental leave, commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits. 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. Reasonable Accommodation
Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. 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 to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
#J-18808-Ljbffr