Production Engineer Assay

Ellume Frederick, MD, USA

Employment Type


The Production Engineer Assay will oversee and engage in assay activities within the Operations division at Ellume.  In the capacity of the Production Engineer Assay, the role will create, validate, and implement reliable manufacturing processes for new assay materials entering the assembly line.


The role will be responsible to oversee daily production activities, investigate problems on the assembly line, implement resolutions as well as seeking opportunities for continuous improvement.  The Production Engineer Assay 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 Production Engineer Assay will ensure all documentation practices are appropriate for medical device purposes and complies with Ellume’s Quality Management System (QMS) policies and procedures.

Duties and Responsibilities

  • Resolve problems by analyzing data, investigating issues, identifying solutions, and implementing resolutions.
  • Write and update DMR / DHF technical documentation to ensure manufacturing processes and facilities maintain a validated state 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.
  • Seek and implement process improvements to improve efficiency on the assembly line (assay specific).
  • Provide adequate training to assembly staff for new and/or changes to assembly processes, documenting training accordingly.
  • Stay current with production specifications and processes, and engineering technology.
  • Manage communication with suppliers, contractors, external clients, and internal stakeholders where applicable. 

Work Experience and Skills

Essential Qualifications:

  • Entry Level or 1-2 years of industry experience in Production Engineering.
  • 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.
  • Knowledge of Lean Manufacturing Principles (LSS).
  • Experience with creating documentation (WINs/SOPs), risk analysis and validation activities.

Education and Certification

Essential Qualifications:

  • Bachelor’s Degree in Mechanical / Electronics / Mechatronics / Biomedical / Chemical Engineering or equivalent.

Desirable Qualifications:

  • Master’s Degree in Mechanical / Electronics / Mechatronics / Biomedical / Chemical Engineering or equivalent.

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: 8 days ago

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