Description:

Research and Development Engineering is responsible for the development and lifecycle management of products through medical device design control processes and good engineering and documentation practices. The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate leader to develop and drive technical strategies. Demonstrates working knowledge of Engineering principles and their application in solving standard technical problems. Demonstrates working knowledge of product design, development, and design control processes. Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Works with moderate guidance to achieve project objectives. Flexible work arrangements allow our team members to collaborate remotely and onsite to experiment, discover, create, and simply connect with others toward a common purpose.

Job Responsibilities:

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices

• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices

• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.

• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies

• Execute design verification testing to confirm design outputs meet design input requirements.

Required Qualifications:

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering

• Work experience of 5 years or 3 years plus an advanced degree

• Critical thinking – able to work with moderate guidance in own area of knowledge.

• SolidWorks or equivalent CAD tool

• Experience with medical device design control processes and creating and maintaining design control documentation.