Process Engineer
at HumCap Recruiting

Date Posted: 3/15/2017

Job Description

Description:  

PREVIOUS EXPERIENCE REQUIRED: 5 to 10
years of experience (minimum)
in process development/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.

 

o   Excellent communication skills.

o   NPI (New product
introduction).

o   Line Transfer to manufacturing
sites. Travel availability is required (approximately 10% to 20%)

o   Feasibility
builds/studies/experimentation.

o   Characterization
builds/ experimentation.

o   Process
development/characterization

o   Statistics (Green Belt
desired), CPK studies minimum.

o   Work Instructions
(SOP)s

o   Testing Procedures,
Leak test, Pull test, Pressure test, Vacuum test, Aging Test, Cross Section,
destructive test, etc.

o   Validation. IQ / OQ
/ TMV /  PQ.

o   Packaging
Validation.

o   Sterilization
Validation.

o   Must have excellent
writing skills to write IQ / OQ / PQ protocols and build protocols and reports,
Work Instructions.

o   Gauge R&R
evaluations.

o   PFMEA.

o   DFx (Design for
Manufacturability). Collaboration with design engineers.

o   Fixture design (only
defining requirements and look for PokaYoke designs).

o   Write User
Requirement Specifications (URS).

o   Lean manufacturing
concepts

o   Cycle Times Studies,
Takt Times.

o   Quality Systems
Knowledge

o   Plastics. Tubing
sets, Ultrasonic Process, laser welding process, Thermal Press.

o   Leak tests
development/evaluation.

o   DOE’s

o   Technical Support to
management team to drive project schedules

o   Communicate well the
ideas (technical) to the customer.

o   Basic knowledge with
Semi-automation Vs Automation.

Job Snapshot

  • Employee Type: Full-Time
  • Location: Irving, TX
  • Job Type: Engineering
  • Experience: Not Specified
  • Date Posted: 3/15/2017

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