NPD Quality Engineer
Posted on :
14-11-2022
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Job Description
Responsibilities:
- The NPD Systems Engineer II is responsible for ensuring a structured and interdisciplinary development approach for product systems from concept to production. The NPD Systems Engineer II considers both the business and the technical needs of all customers with the goal of providing a quality product that meets the user needs. The NPD Systems Engineer II is the technical conscience of the project ensuring the product design intent is maintained through-out the project, and more broadly will also collaborate to create a consistent approach and support across all NPD projects.
- The NPD Systems Engineer II will be the core team member representing the NPD Product Integrity group on a single complex multi-discipline new product development (NPD) project or multiple smaller projects. The NPD Systems Engineer II will represent the Systems Engineering principles to the project teams.
- The NPD Systems Engineer II is capable of identifying technical risk, challenging design decisions, and bridging the gap between the functional elements of the product development process. The NPD Systems Engineer II is accountable for defining customer needs and required functionality early in the development cycle, documenting requirements, leading human factors/usability activities, then proceeding with design synthesis and system validation while considering the complete problem. In order to solve these problems, the NPD Systems Engineer II must collaborate with members of various departments, SME's, Sr Systems Engineers, and internal customers in ongoing decisions regarding study design, data collection, data analysis and methodology.
- Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements. Establish and promote a work environment amongst co-workers that supports compliance with the TMC Quality System and Terumo's policies
- Provide cross-functional leadership as the Product Integrity group member on new product development (NPD) projects.
- Provides oversight to the technical team to ensure a consistent approach in product development in order to deliver a product that meets customer needs.
- Coordinate cross-functionally and with outside partners to deliver results and ensure a quality product that meets customer needs.
- Troubleshoot systems level issues through hands-on or group problem solving activities by considering a systems level perspective that takes into account how changes impact the overall system.
- Lead activities to ensure the product is clinically acceptable by coordinating human factors and clinical testing activities.
- Participate in all design, development and testing activities to ensure the product design intent is maintained through-out the project.
- Coordinate product specification and design input development with the cross functional team by considering the needs of all customers and stakeholders, internal and external.
- 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 submitted to the FDA to support new product clearance or claims.
- Coordinate design verification activities. Prior to verification the Systems Engineer II partners with the technical team in development of test methodology by creating testing strategies that enhance NPD capability in support of new product project execution.
- Coordinate with outside parties for Human Factors/Usability, design, prototyping, testing, etc in support of the implementation of technical aspects of projects.
- Ensure cost viability of the new product throughout the project duration
- Lead special projects as assigned by Mgr., Product Integrity
- Prepare & lead portions of design reviews to a cross-functional team.
- Contribute to project team meetings to provide ideas, methods, or processes for performance improvement.
- Define technical objectives and is responsible for planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc. for assigned projects
- 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.
Employment Type
Full Time
Key Skills
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