NEW PRODUCT DEVELOPMENT ENGINEER

Job Overview

TE Connectivity’s R&D/Product Development Engineering Teams conceive original ideas for new products, introduce them into practice. They are responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp. The R&D/Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D/3D production drawings, product specifications, and testing requirements. They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product. Typical fields of expertise include: materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems.

The Product Development Engineer will develop medical device designs and prototypes, detailed specifications and tolerances, and test methods using TE IVD Solutions ISO Quality Management System. This position may include engineering analysis, prototyping, risk assessment and appropriate qualification testing as deemed necessary.

Responsibilities:

• Evaluate the feasibility of selected concepts to meet functional customer needs
  
• Perform 3D and 2D computer aided design
  
• Design, develop and prototype new products in accordance with ISO 13485 and company Product Development Document (PDD) requirements
  
• Evaluate the feasibility of concepts and/or prototypes through engineering testing and analysis,
  
• Evaluate, document, and implement potential design and process changes to improve product performance, manufacturability, safety or cost
  
• Must have an understanding of new product development technologies and application to company needs
  
• Obtain components, supplies, and equipment to support prototype assembly, and conduct preliminary OEM vendor assessment and selection
  
• Assess reliability, safety, performance and risk of new designs & methodologies; communicate development schedules and compatibility or design issues throughout the team continuously
  
• Provide input into the creation and modification of Product Specifications in alignment with Customer Requirements
  
• Identify, develop and implement pre-production assembly methods and equipment; Coordinate with OEM vendor activities relative to communication of specifications, development schedules, and system compatibility
  
• Transfer of designs to manufacturing through liaison with manufacturing engineering and external suppliers
  
• Travel as needed (domestic and international)

What your background should look like:

• Bachelor’s Degree in Mechanical or Biomedical Engineering and 1 - 3 years of medical device engineering experience preferred.
• Knowledge and experience on microfluidic engineering including: design, fabrication, bioassay and instrument interaction preferred
• User level of most main microfluidic technology tools and systems (e.g. CAD, PCR thermocycler, reagent storage, surface treatment, cartridge actuation & sensing strategies...)
• Capable to learn or perform advanced work on one or more microfluidic techniques (complex CAD designs, bioassay transfer to microfluidics, reliable cartridge to instrument interface...)
• Understanding of ISO13485 standard and impact on product design

Competencies