Engineer I – R & D Disposables

reputed company is a vital organ therapy company focused on advancing kidney care and transforming vital organ therapies. The Engineer I role involves supporting the design and development of product changes for disposable medical devices, including implementing design changes and conducting product testing.

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
• The 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