Process Engineer Medical Manufacturing
at HumCap Recruiting

Date Posted: 7/3/2017

Job Description

Description: Process Engineer Medical Manufacturing Leading Company in
Medical Devices is looking for a Process/Manufacturing Engineer for Long Term
Contract, possibility Contract-to-Hire opportunities. This position is required
to support process engineering group. Perform basically process development for
new projects or existing projects and providing all technical support to
program management and helping achieving the project milestones.

PREVIOUS EXPERIENCE REQUIRED: 5 years of experience
(minimum) in process development and manufacturing in the medical environment.
This experience should include experience with pump systems (example: Insulin
devices, drug delivery systems that involve needles, etc). Experience with
Medical Design development phases (Feasibility, Characterization, DV (Design
Verification), Clinical, PQ-Production. Manufacturing experience is required as
well as experience dealing with product designers, customers, SMEs’.

Experience is required to be a decision maker and drive the
customer or design team with technical background to succeed on the achievement
of project milestones.  This position is
not a management position, however, it is required to have management
experience. This position will require to execute many of the activities
described below as well as being the representative engineer of the process
team in front of the customer. 60% to 70% of the requirements below:

NPI (New product introduction)                  * Write FAT – Factory
Acceptance Tests
Write URS – User Requirement Specifications * Line
Transfer o Feasibility builds/studies o Characterization builds/Studies o Process
development/characterization
Statistics (Green Belt desired), CPK studies
minimum.
Work Instructions o Testing Procedures, Leak
test, Pull test, Pressure test, Vacuum test, Aging Test, Cross Section,
destructive test, etc.
IQ / OQ / TMV PQ (Specifically for Medical
environment) * Gauge R&R evaluations
PFMEA *DFx
(Just collaboration with design engineers sometimes)
Fixture design *Lean manufacturing concepts o
Cycle Times Studies, Takt Times.
Quality Systems Knowledge * Plastics, only for
glue dispensing processes where we need to develop tubing joints.
DOE’s o Technical Support to management team to
drive project schedules *Communicate well the ideas (technical) to the
customer. *Basic knowledge with Semi-automation Vs Automation

Job Snapshot

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