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Senior Instrument Engineer

Employer
Baebies, Inc.
Location
Durham, NC
Start date
Nov 17, 2022

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Job Details

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 purpose

The Sr. Instrument Engineer is responsible for the production, release, and rework of the SEEKER and FINDER instruments within the Operations team. The Sr. Instrument Engineer manages the contract manufacturer(s) that build the instruments, and performs calibration, testing, final assembly, and packaging of instruments. In addition, the Sr. Instrument 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, 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

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 equipment

Preferred Qualifications

  • Experience managing contract manufacturers in the design/process transfer and production of medical device equipment
  • Extraordinary attention to detail
  • Deep understanding of system development and evaluation tools and processes
  • Deeply understands FDA-compliant quality system requirements
  • Highly professional and interested in further professional growth
  • Is strongly engaged by the company’s mission
  • High integrity, insightful, passionate, industrious, and highly intelligent
  • Must be able to work independently and as a member of a multidisciplinary team
  • Excellent verbal and written communications skills; strong computer skills

Working 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 instruments

Direct reports

Instrument Production Technician

Instrument Production Engineer

  

Compensation & Benefits

Baebies 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 & classes

Discount Pet & Legal Insurance

Fertility & Family Support 

· . . . Much more!

   

Baebies, Inc. is an equal opportunity employer. NO RECRUITERS OR AGENCIES, PLEASE.

Company

Baebies was founded in 2014 by Richard West and Vamsee Pamula, following the successful development of digital microfluidics technology, the development and launch of multiple products, and the eventual sale of Advanced Liquid Logic to Illumina, Inc. Baebies has now licensed its core technology, acquired product and manufacturing assets, and built a seasoned management and technical team to pursue opportunities in newborn screening and pediatric testing. Our mission is to save lives and make lives better for all by bringing new technologies, new tests and new hope to children, parents and healthcare professionals worldwide.

Find Us
Website
Phone
(919) 891-0432
Location
25 Parmer Way
Durham
NC
27703
United States
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