Systems Engineer II

Job Summary

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. The salary range for this position is $74,800 - $102,850 based on experience and an 8% target bonus.

Job Details / Responsibilities

• 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 Systems Engineering 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

Working Conditions / Physical Requirements

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 Ability to provide technical oversight to the technical team, lead completion of Design Input documentation and support completion of the product specification.

o Strong analytical and problem solving skills. Ability to solve moderately complex problems and implement solutions or processes. Ability to solve systems level problems by understanding how the changes impact the overall system.

o Strong communications skills to understand and explain complex engineering problems to non-engineering personnel. Ability to create and deliver presentations to executive management. Ability to create detailed Technical Reports appropriate to send to the FDA. Ability to create and train to SOPs.

o Strong coordination skills to align the cross-functional and outside parties to deliver results and ensure a quality product that meets customer

o Ability to implement systems engineering strategies.

o Strong decision making skills. Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make a recommendation.

o Ability to appropriately create documentation to be contained in DHFs or regulatory filings, or in-house engineering.

o Ability to define, write and perform test protocols including design verification for evaluating product performance to confirm specification is achieved.

o Ability to evaluate 3rd parties for capability to provide project support.

o Ability to create and work from engineering drawings and / or specs of products, components, and Marketing requirements.

o Familiarity with mechanical / electronic / chemical equipment and tools in laboratory testing.

o Familiarity with project management principles preferred.

o Practical knowledge of statistical techniques / methods preferred.

o Basic understanding of FDA regulations and design controls preferred.

o 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).

o Experience with creating, reviewing and approving technical drawings

o Knowledge of anatomy & physiology, clinical use of medical products preferred.

o Experience with catheter manufacturing and assembly methods preferred.

Qualifications / Background Experiences