Senior Manufacturing Engineer - Instrument Manufacturing

Company: Baebies Inc.
Location: Durham
Posted on: January 27, 2023

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 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 equipmentPreferred 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 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 AGENCIES, PLEASE.PI202099186

Keywords: Baebies Inc., Durham , Senior Manufacturing Engineer - Instrument Manufacturing, Other , Durham, North Carolina