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Senior Manufacturing Engineer

GTT

Newark, DE

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JOB DETAILS
SKILLS
Agile PLM / Oracle PLM (Product Lifecycle Management), Banking Services, Biology, Biotech and Pharmaceutical, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Capital Equipment, Continuous Improvement, Contract Management, Contract Manufacturing, Corrective Action, Cross-Functional, Dental Insurance, Documentation, Electricity, Electromechanical Engineering, Electromechanics, Field Trials, Financial Services, Fortune 500 Customers, Healthcare, Identify Issues, Insurance Regulations, LabVIEW Programming Language, Leadership, Lean Manufacturing, Manufacturing, Manufacturing Analysis, Manufacturing Engineering, Manufacturing Methods, Manufacturing Operations, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, On Site Support, Operational Improvement, Performance Analysis, Performance Metrics, Problem Solving Skills, Process Analysis, Process Control Engineering, Process Engineering, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Product Lifecycle, Product Support, Purchasing/Procurement, Quality Assurance, Quality Engineering, Quality Metrics, Quality Monitoring, Regulations, Research & Development (R&D), Retail, Retirement Funds, Risk Management, Root Cause Analysis, SolidWorks, Statistics, Technical Leadership, Trend Analysis, Validation Documentation, Validation Plan, Vendor/Supplier Quality Management, Vision Plan
LOCATION
Newark, DE
POSTED
30+ days ago
Primary Job Title:
Senior Manufacturing Engineer
Alternate/Related Job Titles:
Manufacturing Engineer III
Senior Process Engineer
Manufacturing Process Engineer
Senior Industrial Engineer
Electromechanical Manufacturing Engineer
Location:
Newark, DE, United States
Onsite Flexibility:
Onsite
Contract Details (Contract roles only):
  • Position Type: Contract
  • Contract Duration: 9 months
  • Start: As Soon As Possible
  • Pay Rate: $70–75/Hr
Job Summary:
The Senior Manufacturing Engineer provides technical leadership and manufacturing expertise to support a critical contract manufacturing partnership responsible for producing electromechanical capital equipment and high-volume sterile disposables. This role focuses on validating manufacturing processes, driving operational improvements, and ensuring manufacturing quality standards are met within a regulated medical device environment.
The engineer collaborates with cross-functional teams including research and development, quality assurance, procurement, regulatory affairs, and field service to support product lifecycle activities and manufacturing initiatives. The position also plays a key role in implementing Lean manufacturing principles to improve process efficiency, product quality, and operational performance.
Key Responsibilities:
  • Develop and execute validation plans including IQ, OQ, and PQ for manufacturing processes and process equipment.
  • Lead implementation of sustaining engineering initiatives within manufacturing operations.
  • Identify and execute process improvement opportunities using Lean methodologies.
  • Translate complex technical issues into clear summaries for cross-functional stakeholders.
  • Lead troubleshooting and root cause analysis efforts to resolve manufacturing challenges.
  • Develop and update manufacturing documentation including process flowcharts, PFMEA, and process control plans.
  • Facilitate Lean initiatives including kaizen events and continuous improvement programs.
  • Coordinate with contract manufacturing partners to ensure processes follow established plans and risk mitigation strategies.
  • Collaborate with R&D, procurement, design quality assurance, regulatory affairs, and field service teams.
  • Work with suppliers and quality engineering teams to resolve supplier quality issues.
  • Monitor product quality performance and field feedback to identify trends and implement corrective actions.
  • Ensure compliance with organizational quality systems and regulatory requirements.
Required Experience:
  • Bachelor’s degree in Engineering (Mechanical, Electro-Mechanical, Electrical, Industrial, or related field).
  • Minimum 7+ years of experience in manufacturing or manufacturing engineering.
  • Experience supporting electromechanical product manufacturing.
  • Experience performing manufacturing validations and developing validation protocols and reports.
  • Experience leading cross-functional technical initiatives.
Nice-to-Have Experience:
  • Experience working in the medical device industry.
  • Experience working with contract manufacturers and supplier quality management.
  • Experience supporting sterile disposable product manufacturing.
Required Skills:
  • Manufacturing process validation (IQ/OQ/PQ)
  • Lean manufacturing methodologies
  • Manufacturing troubleshooting and root cause analysis
Preferred Skills:
  • Product lifecycle management systems (AGILE)
  • ERP systems such as Oracle, SAP, or BAAN
  • LabVIEW development or integration
  • SolidWorks or other computer-aided design tools
  • Statistical process analysis and validation documentation
Additional Skills:
  • Lean methodologies including 5S, Kanban, SMED, and Value Stream Mapping
  • GEMBA-based operational improvement techniques
  • KPI development and manufacturing performance tracking
  • Process control plan development
  • Supplier quality management and corrective actions
  • PFMEA development and risk management processes
  • Cross-functional collaboration across engineering and regulatory teams
  • Continuous improvement and process optimization strategies
Benefits:
  • Medical, Vision, and Dental Insurance Plans
  • 401k Retirement Fund
About the Client:
Innovative medical technology company focused on improving women’s health and well-being. The organization develops solutions that help detect, diagnose, and treat illnesses earlier while advancing science-driven healthcare technologies.
About GTT:
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.
Job Number:
26-02218
Hashtags:
#LI-GTT #LI-Onsite #gttjobs

About the Company

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GTT

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