Senior Mechanical Technician
Ellume Frederick, MD
- Expired: over a month ago. Applications are no longer accepted.
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 Senior Mechanical Technician is responsible for ensuring the automation equipment used in production at Ellume continues to operate as per quality requirements. The role will support the production process by installing, running, and maintaining highly automated equipment. The role will be responsible for machine set-up, calibration, maintenance, documentation, problem solving issues, and providing initiatives for continuous improvements. The Senior Mechanical Technician is responsible for ensuring their output meets Ellume project timelines. The role is expected to maintain active communication with suppliers, contractors, external clients, and internal stakeholders, where applicable. It is expected that the Senior Mechanical Technician will ensure all documentation practices are appropriate for medical device purposes and complies with Ellume’s QMS policies and procedures. This role will be assigned a rostered shift pattern across mornings/days/nights and weekends as per Ellume production needs.
- Inspect and resolve Production issues on the automated lines by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., equipment stoppages, equipment breakdowns, NCRs, Deviations).
- Write and maintain DMR (e.g., equipment records) / DHF (installation Qualification IQ) technical documentation to ensure manufacturing processes/equipment and facilities are in accordance with Ellume’s QMS.
- Support the purchase, introduction, and implementation of equipment, jigs, and tooling, in line with requirements for Production. Support the development and validation of automated manufacturing equipment into Production.
- Develop and implement mechanical maintenance plans to prevent costly equipment breakdowns.
- Maintain the Maintenance & Calibration schedule, liaising with Production, Planning and Facilities to schedule and plan work.
- Perform preventative and corrective maintenance on mechanical equipment in accordance with the outlined procedures. Where necessary engage external suppliers/contractors to complete these tasks.
- Undertake emergency mechanical repairs and actively source parts to repair and have spare/backups. Liaise with Engineering and Production to develop a list of necessary materials.
- Identify and implement maintenance improvements both short and long term with a focus on autonomous maintenance and prevention of breakdown.
- Follow Workplace Health and Safety standards and Safe Work procedures when conducting tasks on equipment. Report any hazards, incidents, or injuries escalating immediately to the manager or appropriate personnel.
- Other duties as assigned.
“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.
Education and Qualifications
- Engineering / Technical certificate.
- Restricted Electrical License (or previously held).
- Lean Six Sigma (LSS) Yellow or Green.
- High School Diploma or equivalent.
Work experience and skills
- Experience troubleshooting issues with complex systems working methodically through the fault-finding process and where necessary document the process and correction.
- Experience following Workplace Health and Safety standards and Safe Work procedures.
- Experience in working, fault finding, maintenance and calibration of automated manufacturing equipment (i.e., conveyors, bowl feeders, any feeders, tape, and reel).
- Experience using maintenance & calibration records and schedules.
- Experience with creating documentation (WINs/SOPs)
- Excellent written English and documentation skills
- Proficient computer skills, Microsoft Office Suite (Word, PowerPoint, Outlook, and Excel).
- Communication in a clear and timely manner with respect to other areas of business operation.
- Able to multitask, prioritize and manage time efficiently.
Desirable (but not essential):
- Knowledge of ISO 13485 Medical Device standard.
- Experience working in a highly regulated environment (medical device/automotive/defense industry).
- Knowledge and experience of working with Fanuc and Kuka robotics.
- Experience using Plant Maintenance process / software.
- Experience in prevention and control of electrostatic discharge (ESD).
- Experience in high volume manufacturing.
ManufacturingView all jobs at Ellume