Manufacturing Engineer

Job DescriptionManufacturing EngineerPOSITION SUMMARYThe Manufacturing Engineer is responsible for developing, implementing, validating, andoptimizing manufacturing processes for electronics and mechanical assembly operations. Thisrole supports new product introduction (NPI), process development, and continuousimprovement initiatives to enhance productivity, product quality, worker safety, and costefficiency. The Manufacturing Engineer provides technical leadership and hands-on support tomanufacturing operations through process control, root cause analysis, tooling and fixturedevelopment, automation projects, and compliance with quality management systems. Workingcross-functionally with engineering, quality, supply chain, and production teams, this positionensures robust, scalable, and efficient manufacturing processes that support businessobjectives and customer requirements.POSITION GUIDELINES• Effective interpersonal and team leadership skills.• Able to solve complex problems.• Good verbal and written communication skills.• Sound judgement and decision making.• Ability to communicate and implement change.JOB DUTIES & RESPONSIBILITIES• Analyze and optimize manufacturing processes to improve production efficiency, quality,safety, and cost performance.• Develop, document, validate, and maintain manufacturing procedures, work instructions,process flows, and engineering documentation.• Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma,Kaizen, 5S, SPC, and other operational excellence methodologies.• Perform root cause analysis, failure investigations, and implement corrective andpreventive actions (CAPA) to resolve manufacturing and quality issues.• Design, develop, and implement manufacturing fixtures, tooling, and assemblyprocesses for electronics and mechanical assemblies.• Support assembly operations involving soldering, epoxy dispensing, electromechanicalassembly, and related manufacturing processes.• Collaborate with production, quality, supply chain, engineering, vendors, and customersto resolve technical issues and improve manufacturing performance.• Establish process controls, collect and analyze production data, develop laborstandards, and monitor key manufacturing metrics.• Support installation, qualification, and validation of new manufacturing equipment andcapital projects.• Lead new product introduction (NPI) activities, ensuring successful transfer of productsfrom design into production.Job DescriptionManufacturing EngineerEffective Date June 4, 2018• Develop and maintain APQP documentation including Process Flow Diagrams (PFD),PFMEA, Control Plans, MSA studies, and process validation protocols.• Conduct capability studies and equipment/process qualifications including IQ, OQ, andPQ activities.• Support compliance with ISO 9001, ISO 13485, and applicable regulatory requirements.• Identify and implement automation solutions to improve manufacturing throughput,consistency, and product quality.QUALIFICATIONSExperience/Background• Minimum 5 years of Manufacturing Engineering experience in a production environment.• Medical device manufacturing experience required.• Experience supporting mixed electronics and mechanical assembly manufacturingoperations.• Hands-on experience with assembly processes including soldering, epoxy application,tooling, fixtures, and manufacturing equipment.• Experience with process validation, process control, and manufacturing documentationsystems.• Proven success leading continuous improvement and cost reduction initiatives.• Experience supporting high-volume manufacturing environments preferred.• This position requires use of information which is subject to the International Traffic inArms Regulations (ITAR). This position requires individuals who are U.S. persons orprotected individuals within the meaning of ITAR. ITAR defines U.S. persons andprotected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green CardHolder'), U.S. Temporary Resident, Political Asylee, or Refugee.Skills• Lean Manufacturing and Six Sigma methodologies.• APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis.• Process validation methodologies including IQ/OQ/PQ.• Manufacturing automation and equipment integration.• ERP/MRP systems and production planning tools.• CAD software experience; SolidWorks preferred.• Statistical analysis and process capability evaluation.• Microsoft Office Suite proficiency.• Strong problem-solving capabilities.• Proficient in English (reading, writing & verbal skills)• Effective interpersonal skills to drive tasks to completionEducation• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, IndustrialEngineering, or related technical disciplineJob DescriptionManufacturing EngineerEffective Date June 4, 2018POSITION SUMMARYThe Manufacturing Engineer is responsible for developing, implementing, validating, andoptimizing manufacturing processes for electronics and mechanical assembly operations. Thisrole supports new product introduction (NPI), process development, and continuousimprovement initiatives to enhance productivity, product quality, worker safety, and costefficiency. The Manufacturing Engineer provides technical leadership and hands-on support tomanufacturing operations through process control, root cause analysis, tooling and fixturedevelopment, automation projects, and compliance with quality management systems. Workingcross-functionally with engineering, quality, supply chain, and production teams, this positionensures robust, scalable, and efficient manufacturing processes that support businessobjectives and customer requirements.POSITION GUIDELINES• Effective interpersonal and team leadership skills.• Able to solve complex problems.• Good verbal and written communication skills.• Sound judgement and decision making.• Ability to communicate and implement change.JOB DUTIES & RESPONSIBILITIES• Analyze and optimize manufacturing processes to improve production efficiency, quality,safety, and cost performance.• Develop, document, validate, and maintain manufacturing procedures, work instructions,process flows, and engineering documentation.• Lead continuous improvement initiatives utilizing Lean Manufacturing, Six Sigma,Kaizen, 5S, SPC, and other operational excellence methodologies.• Perform root cause analysis, failure investigations, and implement corrective andpreventive actions (CAPA) to resolve manufacturing and quality issues.• Design, develop, and implement manufacturing fixtures, tooling, and assemblyprocesses for electronics and mechanical assemblies.• Support assembly operations involving soldering, epoxy dispensing, electromechanicalassembly, and related manufacturing processes.• Collaborate with production, quality, supply chain, engineering, vendors, and customersto resolve technical issues and improve manufacturing performance.• Establish process controls, collect and analyze production data, develop laborstandards, and monitor key manufacturing metrics.• Support installation, qualification, and validation of new manufacturing equipment andcapital projects.• Lead new product introduction (NPI) activities, ensuring successful transfer of productsfrom design into production.Job DescriptionManufacturing EngineerEffective Date June 4, 2018• Develop and maintain APQP documentation including Process Flow Diagrams (PFD),PFMEA, Control Plans, MSA studies, and process validation protocols.• Conduct capability studies and equipment/process qualifications including IQ, OQ, andPQ activities.• Support compliance with ISO 9001, ISO 13485, and applicable regulatory requirements.• Identify and implement automation solutions to improve manufacturing throughput,consistency, and product quality.QUALIFICATIONSExperience/Background• Minimum 5 years of Manufacturing Engineering experience in a production environment.• Medical device manufacturing experience required.• Experience supporting mixed electronics and mechanical assembly manufacturingoperations.• Hands-on experience with assembly processes including soldering, epoxy application,tooling, fixtures, and manufacturing equipment.• Experience with process validation, process control, and manufacturing documentationsystems.• Proven success leading continuous improvement and cost reduction initiatives.• Experience supporting high-volume manufacturing environments preferred.• This position requires use of information which is subject to the International Traffic inArms Regulations (ITAR). This position requires individuals who are U.S. persons orprotected individuals within the meaning of ITAR. ITAR defines U.S. persons andprotected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green CardHolder'), U.S. Temporary Resident, Political Asylee, or Refugee.Skills• Lean Manufacturing and Six Sigma methodologies.• APQP, PFMEA, Control Plans, SPC, MSA, CAPA, and Root Cause Analysis.• Process validation methodologies including IQ/OQ/PQ.• Manufacturing automation and equipment integration.• ERP/MRP systems and production planning tools.• CAD software experience; SolidWorks preferred.• Statistical analysis and process capability evaluation.• Microsoft Office Suite proficiency.• Strong problem-solving capabilities.• Proficient in English (reading, writing & verbal skills)• Effective interpersonal skills to drive tasks to completionEducation• Bachelor of Science in Manufacturing Engineering, Mechanical Engineering, IndustrialEngineering, or related technical disciplineType: direct hire