Engineer I - R&D Disposables (hybrid)
Vantive
Summary
Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices.
Job description
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.
- 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
- BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
- 0 – 2+ 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.
- 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.
Requirements
- 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
- 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
Benefits
- Medical, Dental & Vision
- Life & Accident Insurance
- Short & Long-Term Disability
- 401(k) Retirement Plan
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Vantive is a leading vital organ therapy company that emerged as an independent entity following its acquisition by Carlyle Group from Baxter International in January 2025. Building on a 70-year legacy of kidney care innovation, Vantive specializes in developing and manufacturing advanced medical equipment for dialysis and vital organ support. The company's comprehensive product portfolio includes peritoneal dialysis systems, hemodialysis equipment, continuous renal replacement therapy (CRRT) solutions, and digital health platforms. Operating in over 100 countries worldwide, Vantive delivers more than 1 million patient touchpoints daily through its innovative technologies and services. The company focuses on transforming vital organ therapies by enhancing accessibility, improving patient outcomes, and providing flexible treatment options for both home and clinical settings. With a mission to extend lives and expand possibilities, Vantive combines decades of clinical expertise with cutting-edge digital solutions to address the complex needs of patients with chronic kidney disease and acute organ failure.