Plastic Manufacturing Process Engineer

4 days ago

Charlotte, North Carolina, United States Peca Labs Full time $80,000 - $120,000 per year

ePTFE Process Engineer — Medical & Industrial

Company:
PECA Labs, Inc.

Location:
South Carolina (on-site) |
Type:
Full-time

About the Role

PECA Labs is expanding ePTFE (expanded PTFE) manufacturing to serve
medical
and
industrial
applications. We're hiring a hands-on
ePTFE Process Engineer
to own deep process understanding, refine production steps end-to-end, and translate material science into stable, high-yield manufacturing.

You'll map and tune every variable that matters—from resin and lubricant through extrusion, stretching, and sintering—to deliver predictable
node-fibril microstructures
and performance properties across multiple product forms (tubes, sheets, membranes, vents).

What You'll Do

Process ownership & optimization

  • Define and lock robust process windows for paste mixing, preform/aging, ram or paste
    extrusion
    ,
    calendaring
    ,
    multiaxial stretch
    ,
    sintering
    ,
    skiving/slitting
    , and winding.
  • Drive yield, scrap, and Cp/Cpk improvements using DOE, SPC, and structured problem solving (A3/8D/DMAIC).
  • Build and maintain golden batch definitions, recipes, and parameter limits; author and update work instructions/SOPs.

Material science & characterization

  • Correlate
    node-fibril morphology
    to properties (density, porosity, air flow, bubble point, WEP, tensile/elongation, creep).
  • Lead test method development and metrology capability (GR&R) across lab and in-line inspection; partner on SEM/DSC/TGA/porometry as needed.
  • Qualify resin grades, lubricant systems, and processing aids; manage change control and supplier variability.

Validation, quality & compliance

  • Plan and execute IQ/OQ/PQ for processes and equipment; drive PFMEA, control plans, and data integrity.
  • Operate within
    ISO 13485 & 21 CFR 820
    for medical and
    ISO 9001
    for industrial lines; support audits and CAPA/NCR closure.
  • Generate DMR/DHR content and contribute to technical files; partner with RA/QA on biocompatibility/sterilization compatibility as applicable.

Scale-up, transfer & NPI

  • Lead tech transfer from R&D to production; own capability studies and PPAP-like packages for industrial customers.
  • Collaborate with Equipment Engineering on upgrades/automation (sensors, recipe control, data capture/SCADA).
  • Convert VOC into CTQs and specification limits; support customer qualifications and on-site technical reviews.

Throughput & reliability

  • Establish OEE baselines and tiered response; implement run-to-run control and targeted debottlenecking.
  • Partner with Supply Chain on resin/lubricant dual-sourcing and incoming QC limits to protect yield.

What You Bring

  • 5+ years
    in polymer/film process engineering;
    ePTFE/PTFE/fluoropolymer
    experience strongly preferred.
  • Demonstrated ownership of extrusion/stretch/sinter workflows and web/tube handling fundamentals (tension control, alignment).
  • Proficiency with
    DOE, SPC, Cp/Cpk, MSA/GR&R
    , and statistics tools (Minitab/JMP).
  • Experience in regulated manufacturing (
    ISO 13485/21 CFR 820
    ) and validation (IQ/OQ/PQ, change control).
  • Comfortable designing and interpreting experiments that link microstructure → property → application.
  • BS/MS in Chemical Engineering, Materials Science, Polymer/Plastics, Mechanical Engineering, or equivalent.
  • s safely and permanently.

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