NPD Engineer Co-op (Development & Technology)
Development & Technology (D&T)
Job Summary: The NPD Engineer Co-op position is responsible for providing technical expertise, leadership and planning to small projects or small portions of large projects. The NPD Engineer Co-op is typically a technical team member. The NPD Engineer Co-op position is specifically accountable for the product design, development, testing, and/or technical problem solving. This position executes the Design for Excellence (DFX) aspect of the processes and product design. Job Details: 1. Perform the design, development, and qualification of products and processes. This may include feasibility studies, designing & implementing evaluations (DOE’s) and providing technical input for justification of project and design. Responsible for contributing to the DHF and regulatory submittals, creating SOP’s, 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 / processes. 3. Perform as a Technical team member on a large project to develop and implement the technical aspects involving design, prototype fabrication and/or testing. 4. Develop and execute projects in accordance with Terumo new 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 performance improvement. 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, NPD engineers and technicians, production personnel, purchasing, logistics, etc…). 9. Implement product performance. 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 product development prototype evaluations, or could be submitted to the FDA to support new product clearance or claims. 10. Performs other job related duties assigned. Working Conditions: 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.
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Position Requirements: To succeed in the NPD Engineer Co-op position, candidates should possess the following KSA’s: • Knowledge, Skills and Abilities (KSA’s) • 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 DOE’s and test protocols for evaluating prototype performance to design criteria. • Background Experience – • 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)
**_Terumo is an Equal Opportunity Employer_**
Affirmative Action/Equal Employment Opportunity Statement
It is the Company’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.