Peca Labs
ePTFE Process Engineer — Medical & Industrial
Company:
PECA Labs, Inc.
Location:
South Carolina (on-site) |
Type:
Full-time
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.
#J-18808-Ljbffr
PECA Labs, Inc.
Location:
South Carolina (on-site) |
Type:
Full-time
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.
#J-18808-Ljbffr