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Job Description:

Must Have 
Engineering Degree-Mechanical or BIO Engineering
3to5 years EXP Medical Device
 Risk Analyst 
 Statistical Background

Responsibilities:

This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment.

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

Scope
• Consultant/ Department expert
• Technical Expertise
• Organizational credibility and knowledge
• Guides and Develops Others
• Influences Others within Department
• Results Oriented
• Business Knowledge
Potential Task Assignments within the scope of this position
1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
2. Maintains a professional working relationship with internal & external customer and support staff
3. Participates and/or leads cross-functional teams.
4. Provides technical support on components, material methods, systems and equipment.
5. Develops physical and functional test requirements to assure specifications & regulations are met.
6. Writes and approves protocols, reports and data.
7. Oversees testing outlined in protocols and test methods
8. Coordinates/develops validation studies on equipment & processes
9. Understands and follows company procedures and regulatory requirements.
10. Participates in and provides input to training on department & division procedures, and policies.
11. Plans and coordinates engineering test builds. 
12. Analyzes problems in design, process and test development. Recommend solutions.
13. Prepares and presents oral and written project updates and technical discussions.
14. Develops and implements procedures to provide easy-to-follow instructions.

Qualifications:

This position requires: 
• an Associate technical degree with 8 (eight) years of engineering experience within the medical device or equivalent industry OR
• a Bachelor degree in science or engineering with 4 (four) year of engineering experience within the medical device or equivalent industry OR
• Masters degree with 3 (three) year of engineering experience within the medical device or equivalent industry OR
• Equivalent experience with 15 (fifteen) plus years of engineering experience within the medical device or equivalent industry 
Quality
Responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will support Manufacturing, New Product Development, and Regulatory to ensure systems are in compliance with all internal and external guidelines.

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