Manufacturing Engineer
Company: Talis Biomedical
Location: Chicago
Posted on: May 28, 2023
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Job Description:
About the CompanyOur purpose at Talis Biomedical is to advance
health equity and outcomes by delivering accurate infectious
disease testing in the moment of need, at the point of care.While
timely diagnosis of infectious diseases is critically important to
enable effective treatment, testing is primarily performed in
centralized laboratories, which require samples to be shipped for
processing, delaying the return of results by days. Point-of-care
testing solves this problem by delivering the timely information
necessary for clinical care.To deliver our purpose we focus on
three things:* Putting customers and patients first* Making Talis a
great place to work* Living our values to Dream Big, Share Our
Screens, Serve Others, Bring Our "A" Game, and Build TrustPosition
SummaryThis position will report to a Sr. Manager Manufacturing
Engineer and will be responsible for developing, documenting, and
validating manufacturing processes for an IVD Consumable.Specific
responsibilities include, but are not limited to:* Develop and
control efficient manufacturing processes for assembly of a
microfluidic cartridge containing injection molded components, wet
and dry reagents, and a wide range of assembly processes.* Operate
pilot automated manufacturing system.* Maintain design and process
documentation including Item Specification, Process Instructions,
BOM, Drawings, etc. Perform change management, including creation
and routing of change orders, identifying appropriate process
impacts, risks, and justification for change.* Help optimize the
product supply chain.* Assist in identifying and procuring
manufacturing equipment ranging from custom large-scale PLC/PC
-based automation equipment to small fixturing.* Plan and execute
design transfer activities, including validation of equipment and
processes, requirements creation, Master Validation Plans, IQ/OQ/PQ
Protocols and Reports, Test Method Validation, Process Flow
Diagrams, pFMEA, etc.* Transfer manufacturing processes to internal
and external suppliers, collaborating effectively across functions
to meet various customer needs, including appropriate training.*
Perform cost reduction, capacity scaling, and quality improvement
activities (equipment and manpower) to meet business needs.*
Participate in CAPA investigations, NCM resolution, failure and
root-cause analysis, and other investigation activities.* Ensure
compliance to Quality System Requirements within an FDA regulated
manufacturing environment.* Leverage a strong understanding of
manufacturing metrics to appropriately select process indicators
that quickly and effectively communicate product and process
health.* May be asked to support pilot manufacturing on automation
system, or other tasks as required by the
company.Education/Skills/Requirements* BS/MS degree in Mechanical
Engineering or equivalent.* 1-3 years of experience in FDA
regulated product development or manufacturing desired.* Excellent
communication, organization, follow-up, and documentation skills.*
Strong problem-solving skills.* CAD experience (Solidworks
preferred).Talis Biomedical offers a comprehensive health and
well-being benefits programs, long-term equity incentives, time-off
policies, a 401(k) retirement savings plan with an immediate
Company match, Education Assistance Program, a rotating suite of
snacks, Happy Hours, office perks, and other fun company events!
Best of all, join us by working at a growing company like Talis
with dedicated and collaborative employees committed to making a
difference in Health Care.Talis Biomedical is proud to be an equal
opportunity workplace. All aspects of employment decisions will be
based on merit, competence, performance, and business needs. We do
not discriminate on the basis of any status protected under
federal, state, or local law. We celebrate diversity and are
committed to creating an inclusive environment for our colleagues.
Talis Biomedical is an E-Verify Participation company.More About
Talis Biomedical:Built on a foundation of world-class science and
engineering, we are developing the Talis One platform, a
sample-to-answer, cloud-enabled molecular diagnostic platform that
could be rapidly deployed to distributed diagnostic settings in the
United States and around the world to diagnose infectious disease
at the point-of-care. The Talis One platform comprises a compact
instrument, single-use test cartridge, and innovative software
including a central cloud database. This system is designed to
provide central laboratory levels of accuracy and be operated by an
untrained user.Talis has raised more than $500 million to date and
went public in February 2021.
Keywords: Talis Biomedical, Chicago , Manufacturing Engineer, Engineering , Chicago, Illinois
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