Participate in cross-functional project teams to implement creative solutions. Monitors performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interfaces with Quality and R&D to integrate new products or processes. Responsible for identifying and correcting manufacturing process nonconformance's identified during prototype builds.
The Sr. Process Development Engineer will be responsible for creating technical solutions across a variety of Cardio & Vascular projects. The engineering role is responsible for the development of innovative manufacturing processes with an emphasis on quality, high yields and process capability. This position will implement product design and process development activities for various catheter platforms.
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.
- Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement.
- Interface 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.
- Project member for new design and development teams for catheters.
- Provide technical expertise to implement catheter processing equipment with a drive to increase process efficiency/product quality.
- Support new equipment/process implementation.
- Provides planning inputs and executes on project deliverables to meet established metrics.
- Conduct process validation activities following IQ/OQ/PQ techniques.
- Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
- Create and analyze prototype products.
- Design experiments to provide data based conclusion about a process or product performance.
- Recommend and rationalize specifications for development products.
- Operate processing equipment in a specific process area.
- Lead and provide input to risk assessment activities such as process FMEA.
- Performs other duties as required.
Education & Experience:
- Minimum Education: Bachelor's degree in related field.
- Minimum Experience: 7+ years' experience.
Knowledge & Skills:
- Must have experience with processing techniques for catheters.
- Experience with FDA/ISO regulations.
- Depth of knowledge in catheter manufacturing technologies, e.g. molding, extrusion, thermoforming, adhesive bonding, split die forming, hot air reflow, braiding, laser and resistance welding, soldering, wire forming, electropolishing, sterilization, etc.
- 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 and external customers.