Job Summary
The NPD Engineer 2 position is responsible for providing technical expertise, leadership and planning to smaller projects. The NPD Engineer 2 is typically a technical team member.
The NPD Engineer II Design Engineer position is specifically accountable for the product design, development, and technical problem solving. This position executes the Design for Excellence (DFX) aspect of the processes and product design.
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, develop, 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. 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 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 and design basic 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. Possess a thorough theoretical and practical understanding of design control requirements, both from a regulatory body perspective and within Terumos systems. Possess ability to implement design control requirements in an effective, efficient, and compliant manner. Ability to train and lead colleagues in the interpretation and implementation of design control activities.
11. 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 will be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.
Knowledge, Skills and Abilities (KSA)
Required: Ability to create a basic technical strategy for a small medical device project or contribute to a large project. Ability to coordinate with applicable cross-functional leaders to gain alignment.
Required: Ability to conceptualize and contribute to the design and development of a new or novel medical device on a bench top or pilot line scale.
Required: Strong communications skills 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. Ability to create and train to SOPÃs.
Required: Ability to implement product design and development strategies.
Required: Strong decision making skills. Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make a recommendation.
Required: Ability to appropriately document new or modified product designs to be contained in DHFs or regulatory filings, or in-house engineering. Ability to create a material specification for any component procured from an outside source.
Required: Knowledge of some DFX processes and tools and their application in medical device product development.
Required: Ability to define, write and perform DOE's and test protocols for evaluating prototype performance to design criteria.
Required: Strong analytical and problem solving skills; ability to solve problems and implement solutions or processes.
Required: Ability to identify potential component suppliers for capability to provide development and production parts or services.
Required: Ability to create and work from engineering drawings and/or specs of products, components, and Marketing requirements.
Required: Thorough understanding of FDA regulations and design controls and ability to apply them effectively within Terumo's systems.
Required: Familiarity with mechanical/electronic/chemical equipment and tools in laboratory testing.
Required: Ability to travel to observe clinical cases, attend trade shows, attend training activities, and visit suppliers, etc. will be required periodically. Vendor credentialing for hospitals is required (i.e. Reptrax).
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
Qualifications/ Background Experiences
BS in Mechanical, Biomedical, or similar engineering discipline. Increasing responsibility in Product Development, Manufacturing Engineering, or Process Engineering in the medical device field and/or an advanced degree in Engineering is preferred.
Demonstrated successful execution of a project including development and documentation.
Demonstrated experience implementing strategies for product design and development based on customer needs and Design Input. Demonstrated design and comparative analysis skills.
Demonstrated successful decision making skills. Experience with performing comparative analyses and making a recommendation.
Demonstrated analytical and logical problem solving abilities. Strong troubleshooting skills for solving process and design issues during product development.
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 and presentation skills. (written communication)
