Sr. Manufacturing Engineer

Masters’ Degree or foreign equivalent in Mechanical, Industrial, or Maintenance Engineering or related engineering field
Requires two (2) years of experience in Manufacturing Engineering for medical devices
Experience must include two (2) years of post-Bachelor’s progressive with each of the following: Completing equipment and process changes and navigating in an FDA regulated environment, ISO 13485 & GMP
Design, evaluation, installation, operation, maintenance and continuous improvement of automated manufacturing equipment, systems, or processes including electrical controls, pneumatics, and PLC
Installation, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes including resistance spot welding, laser welding, anode/cathode fabrication, electrical testing
Performing statistical analysis of Gage R& R, ANOVA, Capability & Normality Assessments
Characterizing manufacturing processes using Minitab/JMP including DOE, SPC, hypothesis testing, regression modelling and capability studies
Manufacturing systems including JDE, FACTORYworks, SPACE and TEMPO
Designing and developing manufacturing tooling and fixtures using CAD
Resolving production quality issues including root cause analysis, product disposition and CAPA

Complete equipment and process changes and navigate in an FDA regulated environment, ISO 13485 & GMP
Design, evaluation, installation, operation, maintenance and continuous improvement of automated manufacturing equipment, systems, or processes including electrical controls, pneumatics, and PLC
Installation, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes including resistance spot welding, laser welding, anode/cathode fabrication, electrical testing
Perform statistical analysis of Gage R& R, ANOVA, Capability & Normality Assessments
Characterize manufacturing processes using Minitab/JMP including DOE, SPC, hypothesis testing, regression modelling and capability studies
Manufacture systems including JDE, FACTORYworks, SPACE and TEMPO
Design and develop manufacturing tooling and fixtures
Resolve production quality issues including root cause analysis, product disposition and CAPA
Sustain and optimize the fabrication process of the Blackwell battery line to meet production, quality, and cost objectives

Bachelors’ Degree or foreign equivalent in Mechanical, Industrial, or Maintenance Engineering or related engineering field
Requires four (4) years of experience in Manufacturing Engineering for medical devices
Experience must include four (4) years of post-Bachelor’s progressive with each of the following: Completing equipment and process changes and navigating in an FDA regulated environment, ISO 13485 & GMP
Design, evaluation, installation, operation, maintenance and continuous improvement of automated manufacturing equipment, systems, or processes including electrical controls, pneumatics, and PLC
Installation, qualification, and validation (IQ/OQ/PQ) of manufacturing equipment and processes including resistance spot welding, laser welding, anode/cathode fabrication, electrical testing
Performing statistical analysis of Gage R& R, ANOVA, Capability & Normality Assessments
Characterizing manufacturing processes using Minitab/JMP including DOE, SPC, hypothesis testing, regression modelling and capability studies
Manufacturing systems including JDE, FACTORYworks, SPACE and TEMPO
Designing and developing manufacturing tooling and fixtures using CAD
Resolving production quality issues including root cause analysis, product disposition and CAPA