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Process Development Engineer

Company: Lumos Diagnostics
Location: Carlsbad
Posted on: February 24, 2021

Job Description:

If you are looking for an environment where you can make a difference, Lumos Diagnostics is the right place for you!
Lumos is currently going through an exciting stage of global expansion, and we are looking for self-motivated individuals who want to help us get there and make a difference along the way.Lumos Diagnostics has an opening for a full-time Process Development Engineer to join its Operations team!
The Lumos Diagnostics Process Development Engineer undertakes activities that contribute to establishing and improving manufacturing processes for a range of technically complex products (both medical and non-medical devices). This role is engaged in the manufacturing support of products to ensure product quality and delivery targets are achieved. This includes root cause analysis of issues and implementation of practical solutions.
Persons working in this position must work under general supervision, independently and as part of a team, following both written and verbal instructions used within the manufacturing and laboratory environment.
Lumos is building a highly experienced team that is passionate about its role in point-of-care diagnostics. Lumos is driving to ensuring they provide the best custom solutions for their partners. To learn more about Lumos Diagnostics, Inc., please visit our website at
DUTIES AND RESPONSIBILITIES

  • Contribute to the establishment and lead the maintenance of manufacturing processes.
  • Participates and leads initiatives to improve the manufacturing process with a focus on lean assembly and manufacturing processes.
  • Manage issues and reports from technicians in an agreed and timely manner.
  • Successful preparation of reports of critical metrics and communication with the client and key stakeholder relationships at a peer technical level
  • Management of specific supplier issues / NCRs
  • Development of plans, schedules improvements for review and approval by Manager
  • Management of specific production engineering improvement projects, with supervision from your Manager, including:
  • Supplier performance improvements
  • Internal process improvement projects/activities
  • Reporting on the status of improvement projects to agreed timescales and budgets.
  • Investigate, troubleshoot, and implement new and improved lean assembly and manufacturing processes.
  • Technically responsible for product drawings, process flow charts, design reviews, and feasibility risk assessments, including relevant engineering documentation for products such as PFMEA, BOMs, and SOPs.
  • Participate in assembly processes within the manufacturing facility.
  • Assessment and qualification of suppliers, including low-cost regions.
  • Management of materials non-conformances, supplier improvements within the CAPA system.
  • Ensure compliance with ISO 13485 manufacturing processes.
  • Regular interfacing with engineers, suppliers, and customers;
  • A significant role in the audit and qualification of suppliers and manufacturing processes.
  • Participates in the identification, planning, and execution of projects involved with process improvement.
  • Supports the qualification of new equipment and performs vendor and site acceptance testing to meet government standards.
  • Participates in troubleshooting and resolving equipment, systems, and process problems to prevent product nonconformity.
  • Designs experimental protocols using statistical tools to determine process response to controllable factors.
  • Develops and implements equipment and process enhancements that will improve efficiency, product yield, and safety.
  • Provides training and support to Operations personnel.
  • Performs other related duties as assigned by management.
    --- QUALIFICATIONS
    • Bachelor's Degree (BS) from a four-year college or university in Chemistry, Biochemistry, Biophysics, bioengineering, or related field strongly preferred.
    • Total compliance with GLP and GMP guidelines
    • Knowledge of experimental design & interpretation
    • Hands-on Assay development and production
    • A minimum of 2 years of lateral flow manufacturing and automation.
    • A minimum of 2 years of engineering experience in a manufacturing environment focusing on process improvement and project management is required.
    • Preferred experience working in an FDA environment.
    • Detailed knowledge and complete understanding and application of principles, concepts, and manufacturing engineering practices are required.
    • Knowledge of government regulatory requirements is required.
    • Experienced in engineering experience in a manufacturing environment of experiments is required.
    • Excellent written and oral communication skills are required.
    • Excellent organizational and interpersonal skills are required.
      BENEFITSLumos Diagnostics offers a broad array of comprehensive, competitive benefit programs that add value to their employees, including medical, dental, 401k with employer match, and paid time off.
      TO APPLYIf you believe your education and experience are in line with the position description and qualifications referred to above and are motivated, energetic, and looking for a new and exciting opportunity, please submit a cover letter outlining your interest in the position along with a detailed CV of your experience.
      No recruitment agencies, please

Keywords: Lumos Diagnostics, San Diego , Process Development Engineer, Engineering , Carlsbad, California

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