A competent Electronics / Mechatronics engineer to work within the engineering department, delivering projects and technical design support for medical device products. The role involves enhancing current designs and creating sustainable product road maps to product end of life. Responsibilities include creating, updating, and re-issuing associated documentation through the company change process, working on new design concepts, and providing technical expertise during project release phases.
Key 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, procure, commission, and document 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.
* Report on systems status and key metrics (pass rates, downtime, costs, etc.) and maintain records to support all activities.
* Effectively manage the introduction of technology on lines, modifications, and process improvements.
* Develop manufacturing technical capabilities and skills to ensure ongoing process requirements can be effectively achieved.
* Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
* Develop strong links with sister plants to ensure effective ongoing 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, ensuring that validations and work methods maintain the highest quality standards.
* Provide technical support in field-related activities such as clinical programs and complaint investigations.
* Provide technical leadership and a structured approach to problem solving for operations personnel involved in process engineering and development activities.
* Present technical data to internal/external audit and inspection groups as required.
* Provide ongoing technical guidance to lead professional work teams and conduct special projects.
* Identify complex problems and their impact on functional objectives.
* Analyze situations, implement solutions, and develop new systems, procedures, or processes.
* Advise other professionals.
* Negotiate approaches and goals.
* Utilize expertise to directly influence other outside departments.
Qualifications:
* Degree in Electrical/Mechanical Engineering with ideally 5 years of relevant experience.
* Familiarity with electronic and electro-mechanical systems design and debug.
* A general knowledge of PCs (DOS, Windows, hardware installation).
* Capabilities in both analog and digital electronics.
* Ability to work as part of a team.
* Willingness to innovate and propose initiatives for new developments and continuous improvements.
* Fluent written and spoken English with excellent record-keeping and report writing skills.
* Basic mechanical aptitude for working with test fixtures and small assemblies.
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