Integer is searching for a Principal Design Engineer to lead next generation solutions for cardio vascular interventional guidewires. The qualified person will be responsible for building technical solutions across a wide variety of cardio vascular device platforms. The position requires someone with a high level of technical and problem solving leadership to drive the design of new products and development opportunities. The role will involve close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.
The primary purpose of this job is to makes decisions and recommendations that are recognized as authoritative and have a far-reaching impact on extensive engineering and related activities of the organization. Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total projects. Reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials. Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications. Devises new approaches to problems encountered. Prepares all necessary paperwork and documentation for all projects undertaken.
Accountabilities and Responsibilities:
- Adheres to Integer's values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Provides planning inputs and executes on project deliverables to meet established metrics. Demonstrates the vision to develop new and unique approaches to solved complex problems advancing systems beyond existing manufacturing technology and capability.
- Ability to be both 'hands-on' and a lead in the design of innovative medical devices for vascular projects. Assignments may begin as initial concepts based on user needs and evolve into prototyping to gain clinical design feedback.
- Authors technical documents including but not limited to: detailed engineering drawings, component specifications, technical memorandums, design verifications/validations, intellectual property applications, input/output matrices, and product specifications.
- Interfaces with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.
- Demonstrates use of lean six sigma practices in development through investigation into root cause for product and process failures, establishing corrective actions and other risk mitigation techniques throughout the design process. Accountable for verification and validation testing to demonstrate product compliance.
- Ensures design for manufacturability, test and compliance meet Integer's and applicable medical device standards. Reviews product specifications for reliability and performance to guarantee customers' expectations are exceeded.
Education & Experience:
- Minimum Education: Bachelor's degree in related field. Master's degree preferred.
- Minimum Experience: 10+ years' experience.
Knowledge & Skills:
- Depth of knowledge in guidewire manufacturing or related technologies in several of the following - grinding, heat forming, molding, extrusion, thermoforming, adhesive bonding, split die forming, braiding, laser and resistance welding, soldering, wire forming, electro polishing, sterilization, etc.
- Demonstrated problem solving skills using lean six sigma techniques as well as proficiency with other root cause and statistical analysis tools.
- Demonstrated design and prototyping capabilities including FMEA, tolerance analysis, design for manufacturability (DFM) and other methods
- Ability to plan, schedule, conduct, or coordinate detailed phases of the engineering work as part of a major project or total project of moderate scope and drive to completion
- Experience with design controls, FDA/ISO regulations.
- Proficiency with mechanical CAD (SOLIDWORKS preferred).
- Advanced knowledge of agile methods of work management a plus.
Knowledge of cardiovascular anatomy and electrophysiology and/or materials science a plus.