MFG & PROCESS DVL ENGINEER I

Job Overview

Job Overview
The Process Development engineer works closely with New Product Development Engineers, Technicians, and Manufacturing engineers to create a preliminary medical device prototype assembly process. From there, the Process Development Engineer will make data driven decisions to invest in error proofing and reducing cost, ultimately resulting in a robust assembly process that can be transferred to high throughput manufacture. This individual must thrive in an environment where collaboration, adaptability, technical expertise of microfluidic device assembly processes, and concise communication are critical to success.

Job Description:

• Acts as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface.
  
• Supports Product Development in the optimization designs and piece parts for manufacturability; realizes sample tooling, product samples and prototypes.
  
• Designs, develops, and qualifies tooling and processes to meet TE quality and production standards.
  
• Documents all processes and tooling in applicable TE systems (Epicore, SAP).
  
• 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.
  
• Work closely with technical team to build pre-production units to meet customer requirements and timelines.

What your background should look like:

Qualifications:

• Bachelor’s degree or higher in Mechanical Engineering, Biomedical Engineering, Mechatronics Engineering, or related field from an accredited university
  
• 3+ years of experience in medical device industry or in design and process development preferred
  
• Experience with Solid Works or other equivalent CAD packages
  
• Experience creating detailed production drawings and documentation
  
• Experience with equipment such as thermal presses, laser welders, laser cutters, metrology systems, ultrasonic welders, and other common assembly equipment
  
• Experience with developing custom equipment and fixtures to satisfy project specific processes
  
• Knowledgeable of manufacturing process requirements according to iso13485, with ability to influence prototype starting at concept stage to ensure design for manufacturability is achieved
  
• Experience working with EHS to ensure equipment and process safeguards are implemented as the procedure requires, and advocates for an ergonomically robust operation
  
• 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 leading technical programs and inter-disciplined groups.

Competencies