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.
