Project Manager-Advanced Operations

What you will do:
• Under supervision, design, develop, modify, and verify mechanical components for medical devices
• Assist with prototyping and bench testing
• Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements
• Under supervision, conduct research and studies to support product design
Business Responsibilities:
• Interpret customer needs and understands design inputs
• Understand the product’s intended use and clinical procedures
• Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements
• With supervision, create or refine engineering documentation, such as the Design History file per company design control procedures
• Learn R&D procedures like design controls and risk management, per the Quality Management System
General Responsibilities:
• With supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
• Learn procedures, policies, processes, systems, and technology required

What you will need:

Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering or Biomedical & 8+ years of work experience

Preferred Qualifications (Strongly desired):

• Fundamental knowledge and understanding of mechanical engineering practices and tools, design principles within a regulated environment.

• Basic knowledge of design and concept generation CAD or CAE modeling tools

• Basic knowledge of analysis tools and statistical methods

• Basic knowledge of materials and manufacturing methods

• Ability to read and Interpret complex drawings