Vantive is a vital organ therapy company focused on advancing kidney care and transforming vital organ therapies. The Engineer I role involves supporting the design and development of product changes for disposable medical devices, including implementing design changes and conducting product testing.
Responsibilities
- 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
- 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
Skills
- BS in Mechanical, Plastics, Biomedical Engineering or a related field
- 0 – 2+ years of related experience in Class II or Class III disposables medical product development
- 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
- Takes initiative with a high aptitude for learning, innovation, 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
- MS preferred
- Design for Six Sigma (DFSS) training or certification preferred
Benefits
- Medical, dental and vision coverage that start on day one
- Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- The Aon Pooled Employer Plan (“Aon PEP”)
- Vantive’s 401(k) retirement savings plan
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- The Employee Discount Program
- The Employee Assistance Program (EAP)
- Childcare benefits
Company Overview
- Vantive US Healthcare LLC specializes in kidney care and organ support therapies with digital solutions. It was founded in undefined, and is headquartered in Deerfield, Illinois, USA, with a workforce of 10001+ employees. Its website is https://www.vantive.com.