Senior Manufacturing Engineer - Instrument Manufacturing
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 Senior Manufacturing
Engineer - Instrument Manufacturing is responsible for the
production, release, and rework of the SEEKER and FINDER
instruments within the Operations team. The Senior Manufacturing
Engineer manages the contract manufacturer(s) that build the
instruments, and performs calibration, testing, final assembly, and
packaging of instruments. In addition, the Senior Manufacturing
Engineer performs troubleshooting on returned instruments and
defines and executes rework procedures. He/She also participates in
the receipt of new instrument designs transferred from product
development. Duties and responsibilitiesManage the contract
manufacturer relationships to include: management of quotes and
purchase orders, scheduling, resolving production
issues/deviations, tracking component inventory, etc. Identify,
develop, and implement continuous improvement and COGS reduction
activities for instrument production, rework, and lot release,
including communicating to and implement such changes at the
contract manufacturer. Participate with Business Unit and contract
manufacturer to develop regular forecast and develop capacity plans
for internal and contract instrument production.Manage and maintain
worldwide inventory of instruments.Provide Design for Manufacturing
input to product development teams, prepare and implement new
processes transferred by the Product Lifecycle Management team, and
communicate operational readiness for production of new
products.Coordinate with product development and contract
manufacture to build new instrument designs used in validation
studies.Manage engineers and technicians performing calibration, QC
testing, SW/FW installation, and final assembly of instruments.
Perform and oversee calibration, QC checks/testing, SW/FW
installation, final assembly, review of lot release data, and
packaging of instruments received from the contract
manufacturer.Responsible for the receipt, troubleshooting, rework,
release, and documentation of instruments returned from the
field.Streamline RMA, receipt, rework, assembly, release and
inventory management processes and transfer appropriate processes
to the ERP system.Collect and maintain QC and production data and
metrics, to include control charts, defect tracking, output,
capacity, WIP inventory, etc., and report performance metrics to
Operations and Business Unit management.Maintain all
instrument-related GMP and QMS documentation and records, including
DMRs, DHRs, pFMEAs, calibration and manufacturing procedures, and
other SOPs. Manage assigned Nonconformance, Deviations and CAPAs,
to include DHR review, root cause investigations, hardware
troubleshooting, and development of correction/preventative actions
and rework procedures. Purchase, install and conduct acceptance and
qualification of instrument manufacturing and calibration
equipment. Execute IQ/OQ/PQ of new equipment and processes.Specify
and use various mechanical and electrical tools and equipment to
conduct mechanical, electrical, and other tests, as well as
dimensional inspections, on new equipment and fixtures.Perform and
document all work according to QMS procedures, specifications, and
test instructions.Maintain the Instrument Lab as a safe and
organized facility that meets all GMP requirements, and serve as
Operations Instrument representative for internal and external
quality audit.Ensure all activities are performed on time, safely,
and in a professional manner.Other tasks as
assigned.Requirements:QualificationsBachelor's Degree or greater in
Electrical, Mechanical, Manufacturing, or Industrial Engineering3+
years of experience in instrument manufacturingDirect experience
with assembly, and qualification of medical device
electromechanical equipmentPreferred QualificationsExperience
managing contract manufacturers in the design/process transfer and
production of medical device equipmentExtraordinary attention to
detailDeep understanding of system development and evaluation tools
and processesDeeply understands FDA-compliant quality system
requirementsHighly professional and interested in further
professional growthIs strongly engaged by the company's missionHigh
integrity, insightful, passionate, industrious, and highly
intelligentMust be able to work independently and as a member of a
multidisciplinary teamExcellent verbal and written communications
skills; strong computer skillsWorking conditionsWorks on-site at
our at our Durham, NC facilityWork carried out in office and lab
environments. Face masks and other personal protective equipment
must be worn in some work locations and situations.Physical
requirementsAble to lift at least 25 lbs unassistedBending,
twisting, reaching, stoopingVisual acuity to perform close visual
inspections and reading of laboratory instrumentsDirect
reportsInstrument Production TechnicianInstrument Production
Engineer Compensation & BenefitsBaebies 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.PI202102751
Keywords: Baebies Inc., Durham , Senior Manufacturing Engineer - Instrument Manufacturing, Engineering , Durham, North Carolina
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