The Senior Staff Manufacturing Engineer works independently overseeing the development, implementation, transfer and improvements of the manufacturing process in accordance with product specification and quality standards. In addition, the Sr. Manufacturing Engineer may be expected to mentor others and be a project leader. 

What you will do:

• Recommend and implement improvements to production processes, methods, and controls. 
• Synchronize manufacturing launch of new or revised products. 
• Responsible for tooling design and process development. 
• Assure product and process quality by designing test methods, testing finished products and process capabilities. 
• Create and approve product drawings, design, and risk documents. 
• Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies. 
• Prepare product and process reports by collecting, analyzing, and summarizing. 
• Evaluate and solve production problems. Apply structural thinking to solve issues (DMAIC/PDCA/Lean Six Sigma 
• Provide robust process analysis based on statistical data 
• Represent manufacturing in cross-functional teams/meeting for new R&D projects. 
• Procure and ensure new equipment and tooling meet installation and operational qualification requirements. 
• Manage manufacturing builds in support of product launch. 
• Train employees on current and new manufacturing processes. 

What you need:

• Reading and preparing technical documentation. 
• Documentation and communication skills 
• Working knowledge of standard machine shop equipment and processes. 
• Expertise with medical device manufacturing equipment and processes. 
• Expertise on medical process transfers  . Understanding of medical and technical development. 
• Computer skills including Word, Excel and SolidWorks Minitab 
• Bachelor’s degree in engineering or related area of study.  
• English proficiency both written and verbal
• Minimum 7 years’ related medical device manufacturing experience. 
• Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes.