1. Perform tooling design and process development. 
2. Assure product and process quality by designing test methods, testing finished products and process capabilities. 

1. Create and approve product drawings and documents. 

1. Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies. 

1. Prepare product and process reports by collecting, analyzing, and summarizing. 

1. Evaluate and solve production problems. 

1. Represent manufacturing in cross-functional teams/meeting. 

1. Ensure new equipment and tooling meet installation and operational qualification requirements. 

1. Target and implement cost reductions. 

1. Train employees on current and new manufacturing processes. 

1. Perform other duties as assigned. 

Qualifications:

1. Reading and preparing technical documentation. 

1. Working knowledge of standard machine shop equipment and processes. 

1. Expertise with medical device manufacturing equipment and processes. 

1. Understanding of medical and technical development. 

1. Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes. 

1. Computer skills including Word, Excel, and SolidWorks. 

1. Must have a demonstrated ability to communicate concepts, ideas, and knowledge effectively and clearly to other individuals and teams both verbally and in writing. 
2. Bachelor's degree in engineering careers required.
3. Minimum 6 years related medical device experience.