The primary purpose of this job is to manage engineering functions. Identify and evaluate procedures and process equipment required to produce a quality product.
The Sr. Design Engineer will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. The engineering role performs assignments involving considerable responsibility including: design of medical devices and sub-assemblies, development of product specifications, analysis of engineering problems and demonstration of design compliance through verification and validation activities. The role requires close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.
Accountabilities & Responsibilities:
Utilizes customer requirements to design innovative medical devices for vascular projects. Assignments may begin as initial concepts based on user needs and evolve into 'hands-on' prototyping to gain clinical design feedback. Integrating and transferring both emerging and existing technologies and materials into guidewire technical capabilities Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement. Develops and documents test methods to evaluate product performance. Leverages ongoing development project technologies to transfer between and aligned efforts throughout the cardio and vascular division Reviews test procedures and plans prior to implementation, conducts failure analysis and inspection on products, processes and materials Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications. Provides planning inputs and executes on project deliverables to meet established metrics. Generates, reviews and approves engineering change orders. Investigates root cause for product and process failures and establishes corrective actions. May supervise and mentor lower level engineers, technicians, and operators. Authors technical documents including but not limited to: technical memorandums, design verifications/validations, input/output matrices, and product specifications. 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
Education & Experience:
- Bachelor's degree in related Engineering field. Masters degree preferred.
- Minimum 7+ years of experience in design
Knowledge & Skills:
- Experience with design controls, FDA/ISO regulations.
- Depth of knowledge in guidewire manufacturing or related technologies, e.g. grinding, heat forming, molding, extrusion, thermoforming, adhesive bonding, split die forming, hot air reflow, braiding, laser and resistance welding, soldering, wire forming, electro polishing, sterilization, etc.
- Proficiency with mechanical CAD (SOLIDWORKS preferred).
- Demonstrated design and prototyping capabilities including FMEA, tolerance analysis, design for manufacturability (DFM) and other methods
- Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
- Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal/external customers and team environment
- Demonstrated ability to lead team activities and act as a coach.
- 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
- Knowledge of cardiovascular anatomy, electrophysiology and/or materials science a plus.