Senior Manufacturing Engineer - Instrument Manufacturing
Company: Baebies Inc.
Posted on: January 27, 2023
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 responsibilities
- Manage the contract manufacturer relationships to include:
management of quotes and purchase orders, scheduling, resolving
production issues/deviations, tracking component inventory,
- 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
- 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
- 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
- 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
- Other tasks as assigned.Requirements:Qualifications
- Bachelor's Degree or greater in Electrical, Mechanical,
Manufacturing, or Industrial Engineering
- 3+ years of experience in instrument manufacturing
- Direct experience with assembly, and qualification of medical
device electromechanical equipmentPreferred Qualifications
- Experience managing contract manufacturers in the
design/process transfer and production of medical device
- Extraordinary attention to detail
- Deep understanding of system development and evaluation tools
- Deeply understands FDA-compliant quality system
- Highly professional and interested in further professional
- Is strongly engaged by the company's mission
- High integrity, insightful, passionate, industrious, and highly
- Must be able to work independently and as a member of a
- Excellent verbal and written communications skills; strong
computer skillsWorking conditions
- Works on-site at our at our Durham, NC facility
- Work carried out in office and lab environments. Face masks and
other personal protective equipment must be worn in some work
locations and situations.Physical requirements
- Able to lift at least 25 lbs unassisted
- Bending, twisting, reaching, stooping
- Visual 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
Keywords: Baebies Inc., Durham , Senior Manufacturing Engineer - Instrument Manufacturing, Other , Durham, North Carolina
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