Remains abreast of and consults on technical advancements.
Identifies and routinely uses the most effective and cost-efficient practices to execute processes
Continually evaluates their effectiveness and appropriateness.
Support all sustaining activities around catheter and capital hardware console manufacturing including end of life, supplier change requests, Global compliance standards, IFU/Label changes, support of regulatory submissions, corporate programs, literature review, and all supporting quality system elements
Support the following manufacturing elements:
Production support process validation, and design changes and design verification and validation
Interface with vendors for components
Support CAPA investigations
Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
Protocol and report writing
Work with cross functional teams as required
Develop and implement process improvements
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels employees, customers, contractors, and vendors.
Works with standard office equipment such as telephone, cellular phone, fax/copier, and a personal computer with standard office software.
May also visit research labs, testing labs, production and other areas as well as vendor facilities as necessary.
Bachelor of Science in electrical/electronic engineering or related engineering field.
A minimum of six (6) + years of relevant work experience in performing the layout construction, and evaluation of a variety of Printed Circuit Boards, fixtures and tools.
Experience with product development a plus.
Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.
Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Knowledge of analog electronics
Experience working in a broader enterprise/cross-division business unit model preferred.
Advanced credential or professional certification in a relevant discipline/concentration desired.
Six-Sigma knowledge and experience desired.
Experience with fiber optics is beneficial
Working knowledge of laser equipment is beneficial