The Manufacturing Engineer will report directly to Operations & Engineering Manager and will be part of Engineering team.
This role will work closely with the production, engineering, and QC teams.
Manufacturing Engineer will support improvements in production processes, production systems and infrastructure, validation/verification activities, and change control activities.
A Manufacturing Engineer will manage, inspect, test and modify the instrumentation, equipment and procedures used for manufacturing, testing and inspection of company products.
Support the testing and validation of new products to meet or exceed internal and external requirements.
Supervision of company change control activities.
Responsibilities:
Primary responsibilities will include:
– Leading engineering projects and activities, including planning, implementation and monitoring of projects
– Analyzing and documenting test results
– Monitoring and testing equipment
– Providing evidence of regulatory compliance
– Help to establish manufacturing inspection, sampling and statistical process control methods, and procedures to assure quality of manufactured products.
– Assures compliance to in-house and external specifications and standards.
– Maintain quality assurance objectives.
– Participate in second- and first-party audits.
– Investigate causes of equipment failures and anomalies and help decide if equipment needs to be repaired or replaced.
– Write, review and approval of company document’s, specifications, validation protocols and reports.
– Managing of change control activities
– Performs other assignments as required by management
– Contributes to process improvements.
– Work closely with production and logistics teams, interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines.
Competencies:
Good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
Excellent writing skills with ability to write Engineering documents and detailed procedures.
Good interpersonal skills to interact with all levels of the company.
Ethical, truthful, sincere, honest and discreet personality.
Education / Experience / Skills:
A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, life-science, medicine, pharmacy, engineering or another relevant discipline.
Knowledge in the field of medical devices/pharmaceuticals and or life- science and at least two (2) years of professional experience in QMS of medical devices or at least 1-3 years of professional experience in QMS relating to medical devices/ pharmaceuticals and or life-science
Experience of 1-3 years in manufacturing engineering and
Proficiency in MS-Office and ERP systems
Must have excellent reading, writing and communication skills in English and Hebrew.
Analytical thinking
Good communication skills
Excellent reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems, work independently and organize and execute multiple work tasks
Ability to read and interpret engineering drawings, product specifications, procedures and standards
Excellent written, oral communication and technical documentation writing skills.