Development Engineer - Materials

Overview

Primarily responsible for demonstrating process feasibility and meeting quality specifications on Lightspeed ADL (i.e. Development) material projects. Assist in transitioning Lightspeed ADL projects to production through the PReP process in a small team and collaborative environment.

Responsibilities

• Define, plan and complete Lightspeed ADL projects
• Work with customers and manufacturing to develop processes to produce wire/tube products
• Perform set up and process development on Nitinol material drawing equipment
• Provide technical skill training to operators
• Provide project guidance to Application Development Technicians and Associate Application Development Engineers
• Lead the successful transition of Lightspeed ADL projects to production
• Support the Site Director in solving on-going production issues
• Apply statistical methods such as design of experiments, SPC, etc
• Support Sales through the completion of quotes
• Generate and update manufacturing routers, inspection sheets, setup sheets, work instructions, and CAPAs as required
• For all work and development, the individual considers and appreciates Good Manufacturing Practices as an evident part of all processes. The individual must also to be a strong supporter of GMP and make it a personal goal to establish such a mind-set.
• Take ownership of assigned tasks and work across several departments as required
• Support cross departmental teams in continuous improvement processes
• Mentor and guide other technical staff to optimized solutions
• Participate in sales support activities including sales presentations, customer visits, and technical seminars
• Other duties as assigned

Qualifications

• Bachelor of Science degree in an engineering/science or equivalent experience
• Familiarity with ISO Quality Systems particularly in medical device manufacturing; ISO-9001/13485 or similar
• Ability to present and convey complex engineering ideas to internal and external customers
• Must possess solid mechanical troubleshooting abilities
• Ability to read and understand engineering drawings using a GD&T system
• Ability to create job related documentation for quality purposes
• Proficient with the use of inspection equipment. This may be defined as a magnifier, microscope, and/or equipment used for measuring capacity
• Ability to quickly and positively adapt to changing priorities and processes
• Strong communication and organizational skills
• Ability to work under minimal supervision

Compensation

Salary Range $85,000-$95,000