*manufacturing process engineer level 2*experience in manufacturing medical components*minimum qualification requirementseducation° bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.° bachelor of science degree in engineering, preferred.minimum 2 years of relevant experience, experience in manufacturing medical components° two years of gmp manufacturing experience in a regulated industry or similar field.° familiar with the assembly of electro-mechanical components*skills*:° ability to read and understand mechanical drawings° demonstrated technical skills in support of on-going manufacturing operations° willingness to learn, takes initiative and demonstrates inquisitive approach to solve moderately complete problems° project management and coordination with cross-functional team members° understanding of gd&t, gage r&r, and correlation studiesjob summaryis responsible for supporting the high volume electro-mechanical assembly of a medical device at a contract manufacturing organization (cmo) to improve process reliability, repeatability, controls, and resolution of manufacturing and quality issues.essential duties° provides hands-on manufacturing support, working alongside of cmo process engineers, to solve problems and identify improvement opportunities° collects data (by measurement or experiment) to support process or design changes° analyzes data and applies statistical analysis including process capability, equivalence, and measurement system analysis (i.e.
gage r&r).
presents it in appropriate forums.° works well in cross-functional teams to prepare and review engineering/technical documents such as protocols, reports, specifications, drawings, and supplier provided documents° collaborates with cmo manufacturing,design team and quality engineers, addressing quality & delivery issues that impact production.facilitates implementation of changes.° follows company and department processes and makes recommendations on these processesthis role is based on-site at a cmo located in the guadalajara technology park.