Engineer I, R&D Disposables

About the Role

Vantive is seeking an Engineer I - R&D Disposables for a hybrid role. This position supports 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.
• 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

• Design for Six Sigma (DFSS) training or certification preferred.
• 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.