Production Engineer - Automation

Ellume Frederick, MD, USA

Employment Type


The primary function of this role will be to support the day to day operations of the Ellume Automated Manufacturing lines. The role will be responsible to oversee daily Production activities related to the 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. 

Duties and Responsibilities

  • Resolve Production issues by analyzing data, investigating issues, identifying solutions, and implementing resolutions (i.e., NCRs, Deviations).
  • Write and maintain DMR / DHF technical documentation to ensure manufacturing processes, equipment and facilities are introduced in accordance with Ellume’s QMS.
  • 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.
  • Plan and complete the purchase, introduction and implementation of equipment, jigs, and tooling, in line with requirements for Production ramp-up volumes and timing.
  • Contribute to Design for Manufacture reviews with R&D
  • Seek, evaluate, analyze, and implement process improvements to reduce cost and/or improve efficiency.
  • Other duties as assigned.

Work Experience and Skills

Essential Qualifications:

  • Minimum 2 years of industry experience in Process Development / New Product Introduction / Production Engineering, or equivalent, within a regulated environment (medical/automotive/defense etc.)
  • Experience troubleshooting issues with complex systems working methodically through the fault-finding process and where necessary document the process and correction.
  • 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 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 Qualifications:

  • 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.

Education and Qualifications


  • Bachelor’s Degree in Mechanical / Electrical / Electronics / Mechatronics Engineering or equivalent


  • 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)

Quality and Safety

All Employees and Contractors are responsible and accountable for: 

  • Compliance with workplace policies for Quality and Safety,
  • Active participation in activities associated with the management of workplace health and safety. 
  • Active participation in activities associated with the management of quality.


Our Company

Ellume U.S.A. is a proud subsidiary of Ellume Ltd. (based in Brisbane, Australia).  We are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers.  We achieve this by applying the working practices of our parent organization through the integration of next-generation diagnostics, reader technology and software.  Our products are distinguished by their simplicity of use, rapid time to result and connectivity.  

  • 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.


The Ellume Way

“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”. 

  • Make it great – we care about great products and general execution.  The best we can possibly create.
  • We are candid – with ourselves and with each other.  Sometimes these conversations are hard, and we deal with those conversations thoughtfully and respectfully.
  • We are a team – we believe in, support, listen to and respect each other.  Together we will achieve great things!
  • We can think – we value quiet contemplation and flying ahead of the plane.  Thought experiments are the best experiments of all.
  • We have a bias for action – thoughts are not our aim.  Our aim is great products and great execution which improve millions of lives.
  • We are bold – we are open to new approaches, strategies, and processes.  Innovation is in our DNA and together we believe we can do the impossible.
  • We are ambitious for the company – through success of the company, we all succeed; our customers, our partners, our shareholders, our communities, and ourselves.
  • We celebrate – individual and team successes at every opportunity.
  • We are driven – to make the future better by inventing it to be so.

Posted date: 26 days ago

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