Ellume is a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for medical practitioners and consumers. We achieve this by integrating next-generation diagnostics, reader technology and software. Our products are distinguished by their simplicity of design, ease of use, rapid time to result and connectivity.
The Automation Engineer role will be required to work across various engineering disciplines, which include Automation, Process Development and Production within the Operations division at Ellume. Duties will be across the entire product development lifecycle as well as ongoing production engineering support, including process improvements, and managing changes of automated systems used to manufacture Ellume products. The role will create, develop, validate, and implement reliable automated manufacturing processes for products entering Production. All products are to be designed for manufacturing and assembly by deploying optimized processes, manufacturing tools and equipment. The role will also be responsible to oversee daily Production activities related to automation equipment, investigate problems on the manufacturing line, implement resolutions, perform validation activities where required as well as seeking opportunities for continuous improvement. It is expected that the Automation Engineer will ensure all documentation practices are appropriate for medical device purposes and complies with Ellume’s QMS policies and procedures.
“Making things great” is one of our most important values at Ellume. We work hard every day to create products that will enhance the lives of people in our community, our country, and all over the world. Doing things great is not an option at Ellume. Working here means making a commitment to uphold the “Ellume Way”.
Our Vision: A world where people return to health as soon as possible.
Our Mission: Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
Our Purpose: To create rapid, accurate diagnostic tools that link people to optimal therapy.
- Develop and deliver validated and reliable automated manufacturing processes for full-scale manufacturing, according to business requirements.
- Work with the R&D, Product Development, Quality, Electrical and Mechanical engineering teams to contribute to process/product design and development. Constructively review designs to ensure quality, efficiency, and optimal cost of products in Production both at Ellume and at contract manufacturing facilities.
- Write and maintain DMR / DHF technical documentation to ensure manufacturing processes, equipment and facilities are introduced in accordance with Ellume’s QMS.
- Plan and complete the purchase, introduction and implementation of equipment, jigs, and tooling, in line with requirements for Production ramp-up volumes and timing.
- Resolve Production issues by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., NCRs, Deviations).
- Perform verification and validation activities including Test Method Validation, PFMEAs, Gage R&R, risk assessments, facility / equipment / process validation (IQ, OQ, PQ) for medical devices within a manufacturing environment.
- Seek, evaluate, analyze, and implement process improvements to reduce cost and/or improve efficiency.
- Provide adequate training of Production staff during process development activities, documenting training accordingly.
- Support and resolve Production process issues by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., NCRs, Deviations).
- Other duties as assigned.
Education and Qualifications
- Bachelor’s Degree in Mechanical / Electrical / Electronics / Mechatronics Engineering or equivalent
Desirable (but not essential):
- Master’s Degree in Mechanical / Electrical / Electronics / Mechatronics Engineering or equivalent
- Lean Six Sigma (LSS) Yellow, Green or Black Belt Qualifications
- Design for Manufacturing and Assembly (DFMA)
Work experience and skills
- Minimum 2 years of industry experience in Process Development / New Product Introduction / Production Engineering, or equivalent, within a regulated environment (medical/automotive/defence etc.)
- Experience troubleshooting issues with complex systems working methodically through the fault-finding process and where necessary document the process and correction.
- Experience in design and development of automated manufacturing equipment.
- Experience with introducing automated manufacturing equipment into production.
- Experience with PLCs for de-bugging purposes.
- Experience in working and fault finding of automated manufacturing equipment (i.e., conveyors, bowl feeders, any feeders, tape and reel).
- Proven competencies in problem solving and developing/optimizing processes.
- Experience with introducing manufacturing equipment into production.
- Experience with creating documentation (WINs/SOPs), risk analysis and validation activities.
- Experience in delivering training to Production staff.
- Experience working with a Quality Management System.
- Excellent written English and documentation skills.
Desirable (but not essential):
- Knowledge of ISO 13485 Medical Device standard.
- Process development and validation experience in the medical device industry; IQ, OQ, PQ.
- Experience with Allen-Bradley PLCs for de-bugging purposes.
- Knowledge and experience of working with Fanuc and Kuka robotics.
- Knowledge and experience of working with Cognex cameras.
- Knowledge and experience of working with OPC servers (i.e., Kepware)
- Experience working with an ISO certified change management process.
- Knowledge of Lean Manufacturing principals.
- Experience in high volume manufacturing.