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Process Engineer

Company: LightDeck Diagnostics
Location: Boulder
Posted on: April 10, 2021

Job Description:

Process Engineer

LightDeck Diagnostics of Boulder, CO (lightdeckdx.com) is seeking to fill the position of Process Engineer. LightDeck is a rapidly growing technology development company focused on next generation products for medical diagnostics, food safety, and environmental applications. The Process Engineer's primary responsibilities will be process development for new and sustaining products, along with technical support of the cartridge manufacturing operations in both LightDeck's pilot plant and new, fully automated production facility.

Job Duties

Subject matter expert responsible for forward-looking, as well as day-to-day, oversite of array printing. Job duties will include process optimization, data analysis and the development of quality tools primarily in support of microarray/fluidic printing and expanding over time to other related processes. All within an FDA Medical Device framework.

Expectations

  • Demonstrated ability to work in a self-sufficient and detail-oriented manner and adhere to manufacturing schedules and deadlines
  • Experience transitioning new products through process development gates and milestones
  • Hands-on experience with database and data management allowing for process performance assessment via GR&R, Yield Tracking, Statistical Process Control (SPC), Correlation studies, and Cpk analysis.
  • Capable of strategizing techniques for streamlined risk management and yield improvement
  • Knowledge concerning process maturation from lab-based procedures to fully-automated continuous-mechanical-assembly (CMA)
  • Proven skills with respect to equipment qualifications and succinct IQ, OQ, PQ documentation
  • Control of biological reagent handling (e.g., antibodies, recombinant proteins) and lyophilization
  • Ability to translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling
  • Skilled in authoring manufacturing Standard Operating Procedures (SOPs) and detailed work instructions
  • Expertise in Design of Experiment techniques and associated software
  • Experience with Acceptable Quality Limit (AQL) quality control methodologies
  • Excellent verbal and written communication skills

    Requirements

    Desired Skills

    Strong preference will be given to candidates with the following skills and experience. No single candidate is expected to have demonstrated all the desired skills listed below. Applicants should highlight relevant experience in any of these areas in a brief cover letter.
    • Manufacturing or other production environment background preferably for medical device, including cleanroom protocols.
    • Direct manufacturing and/or engineering experience with disposable medical devices, particularly in vitro diagnostics
    • Knowledge of microarray printers and fluidic printing considerations and hands-on experience with ultra-low volume dispensing printers for biological reagents
    • Previous experience with plastic bonding processing and injection molding quality and incoming inspection
      • Ability to interpret product drawings. Familiarity with SolidWorks.
      • The candidate should be familiar with Quality Management System requirements with previous work in a regulated environment, under Quality Management System documentation requirements, (ISO 13485/ ISO 9001)
      • Statistical Analysis packages such as JMP, Minitab, Excel, and/or R.
      • Competency with Microsoft Word and Excel.

        Education And Experience
        • Bachelor's or higher degree in engineering or a related field from an accredited university
        • At least 5 years' experience in an R&D or production scale-up environment with project successes directly attributed to the candidate.
          Applicant must have authorization to work in the U.S. Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills. Please email resumes to with applicant name and the job title listing in the subject line. No third-party recruiters needed at this time. No phone calls, please.

          LightDeck Diagnostics, Inc. is an Equal Opportunity Employer committed to a culturally diverse workplace.

          Benefits

          Our organization of -80 people works on proprietary technology that has the potential to have a huge impact on the world (see recent press release on our website). Company benefits include medical, dental, vision, disability, simple IRA with company match, PTO, paid holidays, as well as a casual and collaborative work environment, office snacks and drinks. Located near Boulder's many bike trails, our employees often bike or walk to work. We are committed to work life balance, and seek to support our employees with professional development opportunities that expand their skills and abilities. Come join the LightDeck Diagnostics team today and make a difference!

Keywords: LightDeck Diagnostics, Boulder , Process Engineer, Engineering , Boulder, Colorado

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