Knowledge, Skills and Abilities
Knowledge of FDA Quality System Regulation, ISO-13485, and the Medical Device Directive.
Knowledge of regulatory requirements that relate to process design.
Knowledge of medical device, or drug manufacturing.
Knowledge of design techniques, tools, and principles involved in production of precision technical plans, blueprints, drawings, and models.
Knowledge of statistical analysis.
Ability to organize workload in accordance with project priorities and timelines with focus on execution.
Ability to manage concurrent projects or tasks and coordinate work activities of others as directed.
Ability to effectively lead and work on project teams.
Ability to demonstrate excellent planning, organizational, analytical and communication skills, both verbal and written, to meet the needs of various audiences, ranging from assembler, technicians, peers, and senior management.
Ability demonstrate thorough understanding of budgeting and financial forecasting on a project and business area basis.
Ability to problem solve independently and with others.
Ability to maintain accuracy, consistency and quality of documentation and projects while managing assignments in a fast-paced, multi-task environment.
Ability to function in a controlled environment regulated by FDA GMPs and handle confidential data.
Ability to interact and negotiate successfully with suppliers and vendors.
Ability to take initiative and make decisions within department/company guidelines.
Ability to use word processing, spreadsheet and database computer applications, and to learn various software programs.
Education and/or Experience
BS degree in Electrical Engineering, and five years experience related experience; or equivalent combination of training and experience. Experience with lasers, lights and related equipment manufacturing, Computer Aided Design, and printed circuit board design and rework is preferred. Individual must possess the ability to be recognized as a technical expert and internal consultant to DenMat.
Mid-level industry position
1017 W Central Ave, Lompoc, CA 93436
Lompoc , United States