Engineer - Advanced Operation
Engineer - Advanced Operation
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Job Description
What you will do:
Under supervision design develop modify and verify mechanical components and software 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 products intended use and clinical procedures
Med Device Compliance:
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
Work on problems in limited scope; purposefully learn while gaining experience
Demonstrate ownership and integrity of work
Build stable relationships
Contribute to the project as a team member
What you will Need:
Minimum Qualifications (Required):
Bachelor of Science in Engineering Mechanical Engineering or Biomedical & 35 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
Employment Type
Full-Time
