Process Engineering Co-op

Job Summary

The Engineering Intern or Co-op position is responsible for providing technical expertise, leadership and planning to small projects or small portions of large projects.  The Engineering Intern or Co-op is typically a technical team member.    

The Engineering Intern or Co-op position is specifically accountable for supporting product design, development, testing, and/or technical problem solving.    

Job Details/Responsibilities

1.    Perform the design, development, and qualification of products and processes.  This may include feasibility studies, designing & implementing evaluations (DOEs) and providing technical input for justification of project and design.  Responsible for contributing to the DHF and regulatory submittals, creating SOPs, and for providing training to ensure proper design transfer.  
2.    Implement projects to design, evaluate and qualify new processes for manufacturing new products or improving existing products or processes.
3.    Perform as a Technical team member on a large projects to develop and implement the technical aspects involving design of the product or process, prototype fabrication, and/or testing.  
4.    Develop and execute projects in accordance with the Terumo product development process in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements for medical devices.  This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control and design control requirements.  
5.    Contribute to project performance team meetings in order to provide ideas, methods, or designs for technical improvements.
6.    Prepare & present small technical design reviews to a cross-functional and technical team.
7.    Prepare and present product designs, production processes and related activities to management.
8.    Communicate with various levels in other sections within Terumo for related projects or progress (i.e. daily interactions with managers, supervisors, engineers and technicians, production personnel, purchasing, logistics, etc...).
9.    Define and write test plans/protocols, perform testing, analyze results, suggest recommendations and/or conclusions and document clearly and completely in technical reports.  These reports could be to support both development activity evaluations or submitted to the FDA to support new product clearance or claims.
10.    Performs other job related duties assigned.
 

Working Conditions/Physical Requirements

This position will be located in the Terumo manufacturing facility located in Elkton, MD.  The position will perform required duties in an office environment, the NPD Laboratory and sometimes within manufacturing areas.  Access to hospitals and hospital operating rooms could be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.

Knowledge, Skills and Abilities (KSA)

    Required: Strong written and verbal communications skills.  Ability to understand and explain complex engineering problems to non-engineering personnel.  Ability to create and deliver presentations to management and/or a technical team.  Ability to create detailed Technical Reports appropriate to send to the FDA.  
   Required: Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make a recommendation.
    Required: Analytical and problem solving skills; ability to solve problems and implement solutions or processes.
    Required: Ability to create and work from engineering drawings and/or specs of products, components, and Marketing requirements. 
  Required: Familiarity with mechanical/electronic/chemical equipment and tools in laboratory testing. 
    Preferred: Practical knowledge of statistical techniques/methods.  Knowledge of prototype build methods.
   Preferred: General knowledge of computer aided design, specifically 3-D solid modeling.  
   Preferred: Knowledge of anatomy & physiology, clinical use of medical products.  
    Preferred: Experience with catheter manufacturing and assembly methods 
    Preferred: Knowledge of some DFX processes and tools and their application in medical device product development.
    Preferred: Ability to define, write and perform DOEs and test protocols for evaluating prototype performance to design criteria.
 

Qualifications/ Background Experiences

• Coursework toward a BS in Mechanical, Biomedical, or similar engineering discipline. 
• Demonstrated successful execution of a project including documentation.  Academic project is acceptable.
• Demonstrated successful decision making skills. Experience with performing analyses and making a recommendation.
• Demonstrated analytical and logical problem solving abilities.  
• Demonstrated ability to distill complex technical information and explain to a much less technical audience.  Experience in presenting and explaining to management. (verbal communication)
• Demonstrated strong technical writing skills.  (written communication)