Senior Engineer – Disposables R&D, NPD

• Support or lead projects for the development of new disposable products or product extensions
• Develop user needs and translate them into product requirements
• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools
• 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
• Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance

• BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred
• 3 – 5+ years of related experience in Class II or Class III disposables medical product development
• Design for Six Sigma (DFSS) training or certification preferred
• 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
• 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

Demonstrates expertise in product development for disposable medical products, including risk management, design control, and compliance with FDA regulations. Proficient in utilizing engineering tools and methodologies to translate user needs into product requirements and validate testing processes.

• Product Development
• Design Control Procedures
• FDA Regulations
• Design For Six Sigma
• CAD Software

• Mechanical Engineering
• Biomedical Engineering
• Plastics Engineering
• Injection Molding
• Extrusion
• Ultrasonic Welding
• UV/Solvent Bonding
• Sterilization
• Test Method Validation
• Prototyping

• Collaboration
• Verbal Communication
• Written Communication
• Attention To Detail
• Organizational Skills

• Design For Six Sigma Certification

• Class II Medical Devices
• Class III Medical Devices
• ISO 13485
• ANSI/AAMI/ISO 14971
• Risk Management

• Creo
• Solidworks
• PDM Software