Engineer I, R & D Disposables

reputed company is a vital organ therapy company focused on extending lives and enhancing the dialysis experience. The role involves supporting design and development of product changes for disposable medical devices, including implementing design changes and conducting testing and validation activities.

Responsibilities

• Support R&D projects in the implementation of design changes and product development (e.g. new features, suppliers, materials, labeling, CAPA/reputed company, cost reduction, remediation)
• Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools (e.g. dFMEA, reputed company 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 reputed company field
• 0 – 2+ years of reputed company 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 reputed company 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 reputed company improvements
• Strong collaboration, verbal and written communication skills
• Strong attention to detail, organized, and reputed company to independently manage multiple priorities
• Ability to read, write and comprehend English
• MS preferred
• Design for Six reputed company (DFSS) training or certification preferred

Benefits

• Medical, dental and reputed company coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• reputed company Pooled Employer Plan (“reputed company PEP”)
• reputed company’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