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Manufacturing and Process Development Engineer
hace 2 semanas
TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for excellence in existing manufacturing technologies and methods and striving to implement new manufacturing technologies to provide improved process and tolerance control. They support Product Development in the optimization of designs and piece parts for manufacturability by realizing sample tooling/products/prototypes.
We are looking for an engineer who is highly motivated to work within our Process Development team at our Mondragon location. You will play a critical role in the process development of innovative microfluidic consumables. As part of our team, you will work across multiple internal departments to transform prototypes into manufactured products. Process Development Engineers work with the customer, production, suppliers, and in the engineering lab to develop manufacturing processes. We are looking for people that are hands-on with excellent engineering skills, a team player with leadership skills and is driven to achieve project goals.
**- Develop, characterize, and qualify manufacturing processes from concept through development and transfer to manufacturing of microfluidic consumables, including specifying and procuring required tools and equipment, process flow, process development/verification, and qualification plan.
- Develop process controls leveraging DOE, statistical process control and data analysis
- Designs, develops, and qualifies tooling and processes to meet TE quality and production standards.
- Maintains rigorous records capturing experimental procedures (instructions, controls), and other similar technical information to TE quality standards (ISO13485).
- Supports supply chain to verify supplier compliance and capability.
- Initiates and implements programs to continuously improve quality, cost and cycle time.
- Maintains and adheres to all appropriate specifications, regulatory requirements and customer requirements.
- Create concepts and detail design using design and development methods such as DFMEA, Tolerance Analysis, etc
- Work closely with technical team to build pre-production units to meet customer requirements and timelines.
**Qualifications**:
- Bachelor’s degree (Physics, mathematics or similar) or higher engineering degree (Biomedical, Design, Electronic, Mechanical, Industrial, Telecommunications, Chemical).
- 3+ years of experience in medical device industry or in design and process development.
- Experience in creating detailed production drawings and documentation. User of Solid Works or other equivalent CAD packages.
- Previous experience leading technical programs and inter-disciplined groups.
- Knowledge of LEAN Product Development and processes.
- Self-motivated with attention to detail, deadlines, and reporting.
- Strong analytical and creative problem-solving skills.
- Plus: previous experience working in a lab environment, preferably cleanroom environment
**Competencies**:
- Values: Integrity, Accountability, Teamwork, Innovation
