R&D/PRODUCT DVL ENGINEER II

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.

Short Description

The Clinical Research Associate II (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.

Responsibilities:

• Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelines
  
• Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  
• Record site visit activities, including but not limited to, assessments of qualification initiation activities, observations of clinical conduct, instructions/training given to sites, and action items to be completed
  
• Review and verify accuracy of clinical trial data collected, either onsite or remotely. Provide regular site status information to team members, trial management, and update trial management tools
  
• Complete monitoring activity documents as required by Toolbox OPs or other contractual obligations
  
• Work closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
  
• Perform essential document site file reconciliation. Perform source document verification and query resolution
  
• Assess IP accountability, dispensation, and compliance at the investigative sites.
  
• Communicate with investigative sites
  
• Ensure all required training is completed and documented
  
• Facilitate supply management and ensure clinical sites have the necessary supplies to conduct studies according to applicable protocols
  
• May be assigned additional Clinical Operations tasks
  
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
  
• Help create a fun, rewarding and collaborative environment
  

What your background should look like:

• Bachelor’s degree required, preferably in a Science discipline
  
• Minimum of 2 to 3 years of Clinical Research experience (IVD preferred)
  
• Ability to travel up to 50-75% of the time
  
• Ability to instill trust in our customers through a dedicated effort to achieve their goals with quality, speed and efficiency
  
• Ability to handle difficult situations professionally and maintain a professional and caring demeanor
  
• Proven ability to collaborate in a team environment and work independently
  
• Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment
  
• Must be responsible, creative and highly motivated

Competencies