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):
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:
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