NPD Sr. Engineer II Mech/Biomed

Job Summary

The NPD Senior Engineer II position is responsible for providing technical expertise, leadership and planning to a large or several smaller technical projects.  The NPD Senior Engineer II uses their breadth of engineering knowledge and product development experiences to serve as a technical team leader providing engineering guidance, oversight and coaching to other engineers.  The NPD Sr. Engineer II position is specifically accountable for the product design, development, and technical problem solving of the engineering team working with them. 

Job Details/Responsibilities

1.    Provide engineering leadership in 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 technical strategy and implementation of projects to design, develop, and qualify new processes for manufacturing new products or improving existing products / processes.

3.    Perform as a Technical Lead on a large project to lead and implement the technical aspects   involving coordination with other departments, design, prototype fabrication and/or testing.  Projects & tasks to be completed include organizing and leading members of the D&T group, planning and scheduling technical activities, coordinating technical resources (personnel, materials, time, suppliers), and preparing proper documentation.

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.  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 on behalf of the project technical team in order to provide ideas, methods, or designs for performance improvement.

6.    Prepare & lead technical design reviews to a cross-functional and technical team.

7.    Prepare and present product designs, production processes and related activities to upper 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...) and with counterparts at other Terumo locations.

9.    Implement product performance and design strategies.  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/Physical Requirements

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

Knowledge, Skills and Abilities (KSA)

o    Extensive experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
o    Demonstrated understanding of the cross-functional interactions needed for the development of new products within FDA design control guidelines.
o    Demonstrated understanding of cardiology and peripheral interventional procedures and the medical devices used in those procedure. 
o    Demonstrated strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes.
o    Demonstrated ability to create a development strategy and technical approach for a large medical device project and coordinate with applicable cross-functional leaders to gain alignment.
o    Demonstrated ability to lead the design and development of a new or novel medical device on a bench top or pilot line scale.
o    Strong communications skills.  Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.  
 

Qualifications/ Background Experiences

• BS in Mechanical, Biomedical, or similar engineering discipline with 12+ years of experience with increasing responsibility in Product Development in the medical device field
• Advanced degree in Engineering preferred.