The Systems Engineer I is responsible for ensuring a structured and interdisciplinary development approach for product systems from concept to production. The Systems Engineer I considers both the business and the technical needs of all customers with the goal of providing a quality product that meets the user needs while balancing risks. The Systems Engineer I ensures that requirements definition is clear, and that usability, external standard, and marketing requirements can be defined, verified, and validated while risks are being appropriately being managed and mitigated. The Systems Engineer I will be a core team member on New Product Development (NPD), product transfer, and other projects where a product Subject Matter Expert (SME) is required. The Systems Engineer I will serve as the SME for Systems Engineering principles and drive a customer-centered development approach for the organization. This entails defining clear, unambiguous requirements during the beginning stages of a project, where the systems engineer can decide to use a Quality Function Deployment (QFD) approach or other requirements management tools and methodologies as needed to manage requirements and risk during design iterations. The Systems Engineer I is capable of identifying technical risk, challenge design decisions, and bridging the gap between the functional elements for the life cycle of the product, from initial development through production and retirement. The Systems Engineer I will be involved for both development or post-market release projects to ensure continuity of product requirements as changes are proposed during the product’s life cycle.
1. 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. 2. Ensure a consistent approach to managing product requirements throughout the life cycle of the product. 3. Lead or participate in activities to ensure the product is clinically acceptable by coordinating usability/human factors testing activities. 4. Lead or participate in risk management activities. 5. Lead or participate in product change request evaluations. 6. Lead or participate in root cause activities using appropriate methodologies. 7. 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. 8. Coordinate design verification activities. Prior to verification the Systems Engineer I partners with the technical team during development of test methodologies by creating test strategies that will verify requirements while balancing sample size and resources. 9. Ensure cost viability of the new product throughout the project duration 10. Prepare & lead portions of design reviews to a cross-functional team. 11. Contribute to project team meetings to provide ideas, methods, or processes for performance improvement. 12. Define technical objectives and is responsible for planning and scheduling, coordinating resources as required (personnel, materials, time, budget, suppliers), preparing proper documentation, etc. for assigned projects.
Qualifications Position Requirements: To succeed as a Systems Engineer I the candidate should possess the following KSAs:
Knowledge, Skills and Abilities (KSA’s)
Required: Strong analytical and problem solving skills. Ability to solve complex problems using industry accepted methods and implement solutions or processes.
Required: Strong communications skills to understand and explain complex engineering problems to non-engineering personnel. Ability to create and deliver presentations to the management team (manager or executive level). Ability to create detailed Technical Reports appropriate to send to the FDA. Ability to create and train to SOP’s.
Required: Strong coordination skills to align the cross-functional and outside parties to deliver results and ensure a quality product that meets customer
Required: Ability to develop and support risk management FMECA activities
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 create documentation to be contained in DHF’s or regulatory filings, or in-house engineering.
Required: Ability to define, write and perform test protocols including design verification for evaluating product performance to confirm specification is achieved.
Required: Ability to evaluate 3rd parties for capability to provide project support.
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).
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: Familiarity with QFD or Design For Six Sigma approaches (DFSS).
Preferred: Practical knowledge of statistical techniques/methods.
Preferred: Basic understanding of FDA regulations and design controls.
Required: Experience with creating, reviewing and approving technical drawings.
Preferred: Knowledge of anatomy & physiology, clinical use of medical products.
Preferred: Experience with catheter manufacturing and assembly methods.
Preferred: Familiarity with project management principles.
BS or Advanced Degree (MS) in Systems, Mechanical, Biomedical, or similar engineering discipline with increasing responsibility in Product Development and Systems Engineering preferably within the Medical Device industry.