This position is in the Product Management department within Life Cycle Engineering which focuses on versions of existing medical devices and the continuity of quality supply to the end customer of those existing devices.
The LCE PM Contract Engineer is responsible for functioning as an integral member of a team that develops, designs, validates, verifies & manages a large project portfolio that ensures product quality, cost & performance objectives are met.
Support LCE Project activities including:
Process Development/qualification strategy and execution with minimal direction from senior engineering for:
Components and component tooling
Assembly processes and equipment
Tools and gages
Problem solving and troubleshooting. Six Sigma Green Belt or higher preferred.
Basic engineering (eg. statistical techniques, validation protocol, process capability studies, process validation, developing solutions that meet quality, performance, and cost commitments).
Collaboration skills to work with suppliers & design counterparts to finalize product design, select materials and processes. Also will collaborate with quality engineers, regulatory, marketing and other functions to complete projects.
Recommended Skill sets:
Have Technical working knowledge of & apply / use skills with guidance as related to:
Organizational / planning skills
Must have exceptional collaboration skills
Change Management skills are preferred
Plastic & metallic materials & processing technologies
Equipment development /build activities
Six Sigma Green Belt
Project Management & Project Leadership to deliver to commitments
Engineering Drawing interpretation including GD&T fundamentals
Process development & design practices
Process validation practices (GMP)
Statistical process control
Product design & DFMA (Design for Manufacturing & Assembly)
Risk analysis including use of FMEA
Manufacturing experience is required