Engineer I - R&D Disposables

Vantive • Plymouth, MN

5d • $76,000 - $95,000 • Hybrid

About The Position

Supports design and development of product changes within sustaining engineering and new product development for disposable medical devices.

Requirements

• 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.
• 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.

Nice To Haves

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

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.

Benefits

• medical, dental and vision coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Aon Pooled Employer Plan (“Aon PEP”), Vantive’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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level