ePTFE Plant Manager

Peca Labs; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

A medical device startup is seeking a Plant Manager to oversee PTFE operations in Pittsburgh. The role involves ensuring compliance with regulations, improving manufacturing processes, and leading a team to deliver high-quality medical devices and industrial products. Ideal candidates should have extensive experience in polymer processing and quality systems in a regulated environment.

Qualifications

• 7+ years of experience in polymer processing, particularly PTFE/ePTFE extrusion.
• Demonstrated success in dual-quality systems operation.
• Strong knowledge of paste extrusion mechanics and thermal profiles.

Responsibilities

• Lead all plant operations including production planning and equipment reliability.
• Ensure compliance with FDA regulations and uphold GMP practices.
• Drive lean/Six Sigma initiatives to improve productivity and yield.

Skills

Polymer processing

Quality systems (ISO 13485 & ISO 9001)

Lean/Six Sigma

Cross-functional collaboration

Education

Bachelor’s in Chemical/Mechanical Engineering or Materials Science

Job description

Overview

PECA Labs is a fast-growing medical device startup building next-generation polymeric cardiovascular implants. Our flagship product, exGraft, is a permanently expandable synthetic vascular graft designed to reduce reinterventions—especially in pediatric patients—and to give care teams greater flexibility.

We’re seeking a proven Plant Manager to lead our expanded PTFE (ePTFE) operations across medical and industrial product lines. You’ll own the full lifecycle—from resin handling and paste extrusion through expansion, sintering, slitting/finishing—while ensuring our cleanroom medical products (e.g., vascular grafts, catheter components, implantable or disposable devices) and our industrial materials (e.g., filtration membranes, gasketing, venting, wire & cable wraps) meet rigorous standards for quality, safety, and on-time delivery.

You’ll balance day-to-day execution with continuous improvement, scaling, and cross-functional leadership to support both regulated medical manufacturing and high-performance industrial production.

Key Responsibilities

• Lead all plant operations: production planning, staffing, training, equipment reliability, preventative maintenance, and capacity management across medical and industrial lines.
• Establish and enforce segregated workflows and controls appropriate to product class (e.g., cleanroom vs. non-cleanroom), including environmental monitoring for medical products.
• Ensure compliance with FDA QSR/21 CFR 820, ISO 13485 (medical) and ISO 9001 (industrial); uphold GMP, robust CAPA, change control, and document control practices.
• Oversee quality deliverables: SOPs, validation/qualification (IQ/OQ/PQ), Lot History/Device History Records (LHR/DHR) for medical; COAs, incoming/raw-material controls, and customer specifications for industrial.
• Drive lean/Six Sigma initiatives to improve yield, uptime, scrap, takt adherence, and cost across both product families.
• Partner with R&D/Process Engineering to transfer and scale new formulations, expansion profiles, and sintering recipes from pilot to production.
• Manage supply chain interfaces (fine powder PTFE, lubricants, mandrels, tooling) and maintain inventory, traceability, and vendor quality.
• Track and report KPIs (output, OEE, FPY, complaints/NCRs, EHS metrics) and lead root-cause investigations with timely corrective actions.
• Champion a culture of safety, accountability, and teamwork for a small, high-ownership organization.

Qualifications

• Bachelor’s in Chemical/Mechanical Engineering, Materials Science, or related field (advanced degree a plus).
• 7+ years in polymer processing—ideally PTFE/ePTFE extrusion, expansion, and sintering—with leadership experience in medical devices and/or advanced industrial materials.
• Demonstrated success running dual-quality systems (ISO 13485 & ISO 9001) and operating within FDA QSR/GMP environments.
• Strong knowledge of paste extrusion mechanics, thermal profiles, stretch ratios, porosity control, and downstream finishing.
• Proven use of lean/Six Sigma and data-driven problem solving; comfort with high-mix, small-team settings and broad responsibility.
• Excellent communication, planning, and cross-functional collaboration skills.

Location

Pittsburgh, PA

Employment type

Full-time