Engineering Tech

Engineering Tech

Location:

Sarasota, FL

Duration: 12 Months

• 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.

• 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.