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Production Engineer

Frederick, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

The Production Engineer will work within the Process Development & Production Engineering team within the Operations division at Ellume.

In the capacity as a Production Engineer, the role will be responsible to ensure daily Production processes continue as per Ellume requirements, investigate problems on the production line, implement identified resolutions, performing validation activities where required as well as seeking opportunities for continuous improvement. Where required, the role will support process development by developing, validating, and implementing reliable manufacturing processes for products entering Production.

The Production Engineer 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 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 and facilities are introduced in accordance with Ellume’s QMS.
  • Perform verification and validation activities including Test Method Validation, PFMEAs, Gauge 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.
  • 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 developing and validating reliable manufacturing processes industrialized for full-scale manufacturing, according to business requirements.
  • Participate and provide expertise in design for manufacture and assembly (DFMA) as well as design transfer to Production.
  • Stay current with product specifications, engineering technology and production processes.
  • Manage communication with suppliers, contractors, external clients, and internal stakeholders, where applicable.

Work Experience and Skills

Essential Qualifications:

  • Minimum 2 years of industry experience in Process Development/Production Engineering, or equivalent, within a regulated environment (medical/automotive/defence etc.)
  • Proven competencies in problem solving and developing/optimising processes.
  • Experience with creating documentation (WINs/SOPs), risk analysis and validation activities.
  • Excellent written English and documentation skills.
  • Ability to work under pressure and to tight timelines.

Desirable Qualifications:

  • Knowledge of ISO 13485 Medical Device standard.
  • Process development and validation experience in the medical device industry; IQ, OQ, PQ.
  • Experience with introducing manufacturing equipment into production.
  • Experience working with a Quality Management System.
  • Experience in delivering training to Production staff.
  • Knowledge of Lean Manufacturing principals.
  • Experience developing lateral flow immunoassay manufacturing processes.
  • Experience developing manual assembly processes.
  • Experience working on flow wrapper machines within manufacturing.

Education and Certification

Essential Qualifications:

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

Desirable Qualifications:

  • 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.



Frederick, MD
21703 USA



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