Process Engineer

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 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