Electromechanical Engineer

A competent electro-mechanical engineer to work within the Sustaining Engineering Department, to deliver projects and technical design support for medical device products. To support component obsolescence projects and production requests for our cutting-edge medical device products. The role will provide the person the opportunity to assist in failure investigations, fault finding techniques, research of alternatives parts, work instruction and procedure updates, drawing updates etc. To work on new design concepts and projects identified for transfer to the current manufacturing location and provide technical expertise during the project release phases. To partner with other departments to work on product compliance and quality related activities.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• Strong knowledge of electro-mechanical systems design and debug.
• To review obsolete component issues and lead the identification and specification review of alternatives and associated implementation efforts.
• CAPA Management & generation and adherence to GMP.
• Communicates project status and escalates issues to direct manager, program managers, internal and external partners in timely fashion and with appropriate process.
• To effectively manage the introduction of technology on product lines and process improvements.
• Manage health and safety aspects of equipment and provide user training.
• Support other departments as required, e.g., assist in analysis of customer returns, debug, root cause analysis, technical support for customers, conduct tests in the Laboratory, etc.
• Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
• Develop strong links with our sister plants to ensure effective on-going transfer and sharing of products, processes, and systems.
• In response to in-house quality levels and product complaints, develop process improvement projects to achieve the highest quality standards.
• To provide technical leadership and structured approach to problem solving for operations personnel involved in process engineering and development activities.
• To present, where appropriate, technical data to internal / external audit and inspection groups as required.
• Provides ongoing technical guidance to lead professional work teams, conducts special projects.
• Utilises expertise to directly influence other outside departments.
• Frequently contributes to the development of new ideas and methods.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:

• Honours Degree in Electro-mechanical, Electronic, Mechanical, or related Engineering discipline, with ideally 2-5 year’s relevant experience.
• Master Level Qualification an advantage.
• Strong working knowledge of ISO 13485 and 21CFR820
• Track record of exposure to other International Regulations such as 60601
• Familiar with electro-mechanical systems design and debug.
• Willing to innovate and propose initiatives for new developments and continuous improvements.
• Fluent written and spoken English with excellent record keeping and report writing skills.
• A proven track record of leading and executing Process Validations.
• CAPA Ownership.
• Accountability & Management. 

Key Competencies Required

• Technical competency in reading schematics (both electrical and mechanical)
• Good planning and organizational skills
• Good interpersonal and communications skills
• Proven ability to interpret complex and new situations, anticipates problems or opportunities, assess impacts / risks.
• Develops and implements solutions.
• Adapts to negotiate with peers for common agreement.
• Influences others, (departments & management)

Personal Competencies

• Pro-active with proven ability to work under own initiative.
• Strong team player
• Excellent planning and organizational skills
• Good interpersonal and communications skills
• MS Office, including MS Project
• Ability to lead teams both onsite and remotely.
• Willingness to travel to other Integra or vendor sites as part of duties.