- 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
- 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. Lead/Drive cost saving programs
- 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
Minimum Qualifications (Required): Bachelor of Science in Engineering, Mechanical Engineering 2+ years of work experience
Preferred Qualifications (Strongly desired): Technical Skills:
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
