*manufacturing process engineer level 2*
*experience in manufacturing medical components*
minimum qualification requirements
education
° 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 studies
job summary
is 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 processes
this role is based on-site at a cmo located in the guadalajara technology park.