What are the responsibilities and job description for the Senior Manufacturing Engineer position at Global Technical Talent, an Inc. 5000 Company?
Primary Job Title:
Senior Manufacturing Engineer
Alternate/Related Job Titles:
Manufacturing Engineer III
Senior Process Engineer
Manufacturing Process Engineer
Electromechanical Manufacturing Engineer
Lean Manufacturing Engineer
Location:
Newark, DE
Onsite Flexibility:
Onsite
Contract Details (Contract roles only):
- Position Type: Contract
- Contract Duration: 10 months
- Start: As Soon As Possible
- Pay Rate: Not specified
The Senior Manufacturing Engineer serves as a key technical interface supporting contract manufacturing operations for electromechanical capital equipment and high-volume sterile disposable products. This role focuses on manufacturing validation, process improvement, and cross-functional collaboration to ensure high-quality production and operational efficiency.The engineer will work closely with internal teams and external manufacturing partners to implement manufacturing initiatives, troubleshoot production challenges, and drive continuous improvement using Lean manufacturing principles.
Key Responsibilities:
- Create and execute validation plans including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for process equipment and manufacturing processes.
- Lead manufacturing implementation of sustaining design initiatives.
- Identify and execute process improvement opportunities using Lean methodologies.
- Translate complex technical issues into clear summaries for stakeholders.
- Lead troubleshooting efforts to resolve manufacturing issues efficiently.
- Develop and maintain process documentation including process flowcharts, PFMEA, and process control plans.
- Facilitate Lean Kaizen events and apply Lean manufacturing practices.
- Collaborate with contract manufacturing teams to ensure project plans are executed and risks are mitigated.
- Work cross-functionally with R&D, Procurement, Design Quality Assurance, Regulatory Affairs, and Field Service teams.
- Coordinate with suppliers and Quality Engineering teams to address supplier quality issues.
- Monitor product quality reports and field performance trends, and implement corrective actions.
- Ensure adherence to company quality policies and quality system procedures.
- Bachelor’s degree in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering.
- Minimum 7 years of manufacturing or manufacturing engineering experience.
- Experience working with electromechanical assemblies.
- Experience within the medical device industry.
- Experience writing and executing validation protocols and reports.
- Experience managing projects and coordinating cross-functional teams.
- Experience using PLM systems such as AGILE.
- Experience working with ERP systems including Oracle, SAP, or BAAN (Oracle preferred).
- Experience with LabVIEW.
- Experience using CAD software such as SolidWorks.
- Manufacturing validation (IQ, OQ, PQ)
- Lean manufacturing and continuous improvement
- Process documentation and PFMEA development
- ERP and PLM systems (Oracle, SAP, Agile)
- LabVIEW and automation systems
- CAD tools including SolidWorks
- Statistical analysis and process validation methods
- Lean methodologies including 5S, Value Stream Mapping, Kanban, SMED, and GEMBA practices
- KPI development and performance monitoring
- Manufacturing troubleshooting and root cause analysis
- Cross-functional collaboration with engineering and regulatory teams
- Supplier quality management
- Process improvement leadership and facilitation of Kaizen initiatives
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
An innovative medical technology company focused on improving women’s health through advanced diagnostic and treatment solutions. The organization develops science-based technologies that enable earlier disease detection and improved healthcare outcomes.
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:
26-02217Hashtags:
#gttjobs