Engineering Tech

PRIMARY RESPONSIBILITIES:

" Work side by side with Design and Controls Engineers in equipment assembly and debug.

" Support Manufacturing and Quality Engineers in process validations of new and existing equipment

" Understand and execute SOPs and Work Instructions

" Develop and Write SOPs and Work Instructions

" Support development and maintenance of videos to supplement work instructions.

" Support development and modification of Preventive Maintenance routines.

" Use industrial CT scanning equipment for validation and digital metrology.

Qualification:

Bachelor s degree in engineering or science required.

Required Knowledge, Skills, and Abilities:

Minimum 3 years full time experience

Demonstrated knowledge of Six Sigma methodology, SPC techniques and MINITAB data analysis.

Three (3) years of practical medical device manufacturing experience is preferred.

Working knowledge of FDA, cGMP and ISO Standards/regulations.

Good working knowledge of process validation, including protocol development.

Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate quality risks

Strong process validation knowledge and background

Test method development and documentation.

Experience with ASTM methods.

Strong problem-solving skills and ability to make firm decisions.

Organization and analytical skills.

Knowledge of lab equipment, instruments and calibration procedure.

Ability to work in a cross-functional team setting.

Detailed oriented, high energy, self-starter, who exercises sound judgment and deliver against company business goals and objectives.

Excellent communication, and presentation skills, both orally and written.