Engineer I, R&D Disposables

About the Role

Vantive is a vital organ therapy company focused on extending lives and expanding possibilities. This role supports the design and development of product changes within sustaining engineering and new product development for disposable medical devices.

Key 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.

Requirements & Tech Stack

• 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.

Qualifications

• 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.