Process Development Engineer
Company: Lumos Diagnostics
Posted on: February 24, 2021
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
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
DUTIES AND RESPONSIBILITIES
- Contribute to the establishment and lead the maintenance of
- Participates and leads initiatives to improve the manufacturing
process with a focus on lean assembly and manufacturing
- Manage issues and reports from technicians in an agreed and
- 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
- Assessment and qualification of suppliers, including low-cost
- Management of materials non-conformances, supplier improvements
within the CAPA system.
- Ensure compliance with ISO 13485 manufacturing processes.
- Regular interfacing with engineers, suppliers, and
- 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
- 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.
- 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
- 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
- Knowledge of government regulatory requirements is
- Experienced in engineering experience in a manufacturing
environment of experiments is required.
- Excellent written and oral communication skills are
- Excellent organizational and interpersonal skills are
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
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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