Sr Engineer- R&D Disposables

Vantive • Plymouth, MN

2d • $88,000 - $121,000 • Hybrid

About The Position

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 Role Supports design and development of product changes, within sustaining engineering, for disposable medical devices. What you'll be doing Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (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

Requirements

• Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
• Working knowledge of CAD 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
• Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements
• Strong collaboration, verbal and written communication skills
• Strong attention to detail, organized, and able to independently manage multiple priorities
• Ability to read, write and comprehend English
• BS in Mechanical, Plastics, Biomedical Engineering or a related field
• 3 or more years of related experience in Class II or Class III disposables medical product development

Nice To Haves

• A Master of Science degree
• Design for Six Sigma (DFSS) training or certification

Responsibilities

• Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level