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Operates anyone of the following technologies: Delicate assembly, Dispensing, Compression molding, Encapsulation. Assure product complies with its specifications, cGMP's and SOP's to guarantee on time and high-quality product. This position holder must comply with all regulations and the current Good Manufacturing Practices required by the job function.
Operate manual and semi-automated tooling to manufacture a medical device intended for implantation in humans.
Assure that all manufacturing documentation related to the manufacturing and cleaning operations are completed as required by manufacturing instructions.
Clean and sanitize production areas (manufacturing room and preparation room), storage containers (bins or vessels), and process equipment according to standard operating procedures.
Reporting to: VP Engineering.
Skills and Qualifications:
Practical engineering or Higher Diploma with three years or more of experience in one of the following medical device manufacturing technology areas: dispensing, mechanical / optomechanical assembly, encapsulating in a clean room class 7 or higher environment.
Candidates should be self-motivated team players that are eager to assist and learn from the Engineering team as needed.
Ability to read working instructions and write production data in English.
Operate MS Excel & MS Word fluently