Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO.
Ability to make and present engineering decisions
Strong interpersonal skills
Engineering cost analysis
Ability to analyze and optimize manufacturing and quality systems
Ability to create and provide training
Software application skills
Problem solving ability
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
Ability to work on cross functional teams
Must read, write and understand English. Must be detailed in handling information/data.
Basic product, design & prototyping skills
Proficient with Microsoft Excel
Familiar with Minitab and Statistical Analysis