Overview

A competent Electronics engineer, with digital and analogue electronics experience, to work with the existing Sustaining Engineering team to deliver projects and technical design support for medical device products. To assist in enhancing current designs and help create sustainable product roadmaps to product end of life. To create, update and re-issue associated documentation through the company change process. To work on new projects identified as to be transferred to the current manufacturing location and provide technical expertise during the project release phases. To provide a high-level knowledge transfer to help the Operations Engineering team provide diagnostic, test, debug and support to the manufacturing area. To lead electronics projects in product Life Cycle Management, sourcing, and validation of alternative components to ensure business continuity and compliance. To lead and execute Design Verification and Process Validation for product and process changes and New Product Introduction projects.

Qualifications

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

Degree in Electronic / Electrical Engineering or similar discipline, with ideally 3-5 year’s relevant experience.
Familiar with electronic and electro-mechanical systems design and debug.
Working knowledge of PCs (Windows, hardware installation).
Strong capabilities in both analogue and digital electronics.
Ability to work as part of a team.
Willing to innovate and propose initiatives for new developments and continuous improvements.
Basic mechanical aptitude for working with test fixtures and small assemblies.
Fluent written and spoken English with excellent record keeping and report writing skills are required.

Key Competencies Required

Electronic design control & debug experience – current technologies.
Technical competency in reading electronic design schematics and datasheets.
Leads multifunctional teams, conducts special projects, may manage technical departments.
Willingness to travel to other Integra sites as part of duties

Key Competencies PREFERRED:

Knowledge on Cadence OrCAD and LabVIEW
Knowledge of Medical Devices standards (ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, etc.).
Experience supporting external audits (FDA, MDSAP, EUMDR, etc.).

Responsibilities

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

Write, manage and maintain production test specifications and related work instructions for all sub-assemblies and products.
Design, prototype, procurement, commissioning and documentation of test equipment, and fixtures. Manage health and safety aspects of test 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 Test Laboratory, etc.
Liaise with Product Development to provide DFT (Design For Test) inputs at an early stage in product design.
To effectively manage the introduction of technology on production lines, process modifications and process improvements.
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.
Generate Process and Test method validation protocols and reports. Ensure that process validations and work methods are adequate to maintain the highest quality standards.
Provide technical support in field related activities such as clinical programmes, complaint investigations, risk assessments and CAPA process.
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.
Identifies complex problems and their impact to functional objectives.
Analyses technical challenges, implements solutions, and develops new systems, procedures or processes.
Advise other professionals and utilises expertise to directly influence other outside departments.

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ELECTRONICS ENGINEER