Process Engineer
Company: Baebies Inc.
Location: Durham
Posted on: January 27, 2023
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Job Description:
Description:Baebies is a medical device company that develops
and commercializes newborn screening and near-patient testing
products for children and adults to enable early disease detection
and comprehensive diagnosis. Guided by the vision that everyone
deserves a healthy start," our mission is to save lives and make
lives better for all by bringing new technologies, new tests, and
new hope to children, parents, adult patients, and healthcare
professionals worldwide. Job purposeThe Process Engineer is
responsible for the design, assembly, characterization, and
transfer of new cartridge production and testing equipment within
the Product Lifecycle Management (PLM) team. The Process Engineer
will design and develop new and novel manufacturing and testing
processes and equipment that enables high quality, cost efficient,
and scalable production of new assays and cartridges introduced by
the new product development teams. In addition, the Process
Engineer will improve existing processes and equipment to drive
continuous improvement and cost reductions, and develop and build
prototype and pilot equipment and processes to support R&D
development teams.Duties and responsibilitiesDesign, specify,
fabricate, assemble, and integrate new cartridge production (e.g.,
reagent spotting, drying, filling, sealing, gluing, curing,
pick-n-place, etc.), inspection, and testing equipment, as well as
related fixtures, for process development for new product
development projects.Lead the design and development of
improvements to existing processes and equipment that result in
quality improvement, defect/scrap reduction, increased output,
decreased downtime and changeovers, and the reduction in labor and
other costs to improve quality and reduce product costs. Design,
specify, fabricate, assemble, and integrate prototype and pilot
production and testing equipment in the R&D lab that produce
cartridges and other consumables used by the R&D development
teams.Design and execute statistically-valid characterization
experiments, including Design for Experiments (DOE) studies, of new
equipment and processes that minimizes sources of process variation
to produce high quality cartridges in a cost efficient and scalable
manner.Collaborate with new product development teams and provide
Design for Manufacturing/Design for Automation (DFM/DFA) input on
new products, beginning at the initiation of the development phase,
which enables high quality, low cost, scalable commercial
manufacturing. Identify suppliers of and select novel assembly,
inspection, and test equipment, and related systems, and coordinate
the design of custom solutions for Baebies products. Lead the
procurement, installation, start-up and FAT and SAT testing of new
equipment, as well as their integration with other new and existing
equipment and systems. Lead the successful transfer of cartridge
production of new products to the Operations team that ensures a
smooth transition from R&D scale to commercial scale Develop
the initial documents needed for document transfer to Operations,
including the process FMEA, cartridge production manufacturing
instructions, equipment requirement specifications, and process
output specifications for new equipment and processes. Specify and
use various mechanical and precision calibrated tools and equipment
to conduct mechanical, electrical, and other tests, as well as
dimensional inspections, on new equipment and fixtures.Provide
Sustaining support for the investigation of cartridge
process-related aspects of customer complaints, product
nonconformance, corrective actions, and other performance issues.
Use a structured root-cause analysis (e.g., DMAIC) to determine the
root cause and develop solutions. Provide support to Operations to
implement process changes.Provide cost input for cartridge
assembly-related costs for the development of COGS estimates during
initial development through Design Transfer. Develop an
understanding of required production volumes for scale planning.
Perform and document work according to procedures, specifications,
and test instructions, where required.Maintain a clean and orderly
laboratory environment.Ensure all activities are performed on time,
safely, and in a professional manner.Other tasks as
assignedRequirements:QualificationsBachelor's Degree in Electrical,
Mechanical, Manufacturing, Process or Robotics engineering or
related field, or Associates Degree in related field with
demonstrated experience of process/equipment design skill3 years of
process development and/or manufacturing experienceDirect
experience with design, specification, assembly, and qualification
of consumable assembly equipment.This is an on-site position at our
Durham, NC facilityPreferred QualificationsDirect experience with
design, specification, assembly, qualification, operation, and
maintenance of high-volume, automated assembly equipment.Experience
in transferring new processes and equipment from R&D scale to
commercial manufacturingExperience in medical device and/or IVD
manufacturing, R&D, or Sustaining engineeringDeep understanding
of process development and characterization tools and methodology,
including DOE design, statistical process control, development of
pFMEA, etc.Experience with process yield improvement, cost
reduction activities, and DFM/DFA Skill in conducting technical
root cause investigations using a structured approach (e.g., DMAIC,
8D) of complex process and equipment issues, generate creative
solutions, and drive implementation of improvements with an
understanding of process impactsSkill in PLC and other programming
Strong electrical design skills preferred including design of new
equipment, drafting of wire-lists, schematics, and
rewiring/redesign of existing productsAbility to write clear,
concise specifications and work instructionsMust be able to work
independently and as a member of a multidisciplinary teamWorking
conditionsIndoor lab environment. Face masks and other personal
protective equipment must be worn in some labs and work
environments. Physical requirementsAble to lift at least 25 lbs
unassistedBending, twisting, reaching, stoopingVisual acuity to
perform close visual inspections and reading of laboratory
instruments/glassware Compensation & Benefits$75,000-$90,000,
dependent on experienceBaebies offers a dynamic and welcoming work
environment surrounded by intelligent, driven, and creative people.
Guided by the vision that everyone deserves a healthy start, our
team is devoted to our customers and to advancing technology in
early disease detection and comprehensive diagnosis. At Baebies, we
look for people who are innovative, dedicated to our mission, and
constantly striving to improve the status quo. In addition to
competitive, market-driven compensation, Baebies provides a
comprehensive employee benefits package including:-- 100% employee
premiums for Medical & Vision coverage-- 100% employee and family
premiums for Dental coverage-- 401K Matching-- Stock Options-- 4
Weeks PTO-- 14 Paid Holidays per year-- Paid Employee Life
Insurance-- Onsite free gym membership & classesDiscount Pet &
Legal InsuranceFertility & Family Support -- . . . Much more!
Baebies, Inc. is an equal opportunity employer. NO RECRUITERS OR
AGENCIES, PLEASE.PI202102772
Keywords: Baebies Inc., Durham , Process Engineer, Engineering , Durham, North Carolina
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