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Manufacturing Engineer

Katalyst Healthcares & Life Sciences
  • Plano, TX
  • Instant Apply
9 days ago

Job Description

Job Summary
We are seeking an experienced Manufacturing Engineer with a strong background in the Medical Device industry to support manufacturing process development, validation, optimization, and continuous improvement initiatives. The ideal candidate will have hands-on experience developing and optimizing manufacturing processes, executing IQ/OQ/PQ process validations, troubleshooting production and equipment issues, and supporting quality and regulatory requirements.

Roles & Responsibilities
  • Develop, characterize, optimize, and implement manufacturing processes and technologies for medical device production.
  • Plan and execute process validation activities, including IQ, OQ, and PQ.
  • Develop and maintain process validation protocols, reports, and supporting documentation.
  • Perform PFMEA/FMEA activities to identify and mitigate manufacturing process risks.
  • Apply Lean Manufacturing and Continuous Improvement methodologies to improve process efficiency, quality, productivity, and cost.
  • Analyze manufacturing data and process performance using Minitab and other statistical/data-analysis tools.
  • Conduct Root Cause Analysis (RCA) and implement effective corrective and preventive actions.
  • Support production troubleshooting and resolve manufacturing process and equipment-related issues.
  • Develop and optimize manufacturing processes, tooling, fixtures, and equipment.
  • Apply Design for Manufacturability (DFM) principles when evaluating new products, processes, tooling, and design alternatives.
  • Collaborate with Design Engineering and R&D teams to ensure products are manufacturable and production ready.
  • Support equipment qualification, installation, and implementation activities.
  • Identify opportunities to improve process capability, yield, throughput, reliability, and overall manufacturing performance.
  • Prepare and maintain engineering documentation, work instructions, process specifications, and validation records.
  • Work closely with Quality Engineering to ensure compliance with applicable quality and regulatory requirements.
  • Support investigations, nonconformances, CAPA activities, and process improvement initiatives as required.
  • Ensure manufacturing processes comply with applicable FDA regulations, ISO 13485, GMP, and company quality-system requirements.
  • Provide technical support to production teams and assist with implementation of process improvements.
  • Communicate effectively with cross-functional teams and manage multiple engineering projects and priorities.
Education & Experience
  • Bachelor's degree in mechanical engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
  • Advanced degree or additional technical certifications in manufacturing, quality, or engineering is a plus.
  • 3 4+ years of experience in Manufacturing Engineering, preferably within the Medical Device industry.
  • Hands-on experience with manufacturing process development, characterization, optimization, and implementation.

Numbers & Facts

LocationPlano, TX

Skills

  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Engineeringunmatched
  • Engineering Managementunmatched
  • FDA Requirementsunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Identify Issuesunmatched
  • Industrial Engineeringunmatched
  • Lean Manufacturingunmatched
  • Machine Toolunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Analysisunmatched
  • Manufacturing Designunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing/Industrial Processesunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Minitabunmatched
  • Multitaskingunmatched
  • Process Capabilityunmatched
  • Process Developmentunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Product Testingunmatched
  • Production Supportunmatched
  • Project/Program Managementunmatched
  • Quality Engineeringunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulatory Requirementsunmatched
  • Research & Development (R&D)unmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Statisticsunmatched
  • Team Lead/Managerunmatched
  • Technical Supportunmatched
  • Technical/Engineering Designunmatched
  • Tool and Die Manufacturingunmatched
  • Validation Planunmatched

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