Director of Finance— PECA Labs
Location: Pittsburgh, PA
Type: Full-time | Reports to: COO | Team: Executive Leadership
About PECA Labs
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.
Division Head, Plastics Manufacturing (ePTFE) — Medical & Industrial
Location: South Carolina (on-site leadership; travel to Pittsburgh, PA HQ as needed)
Employment: Full-time
The Role
We’re seeking a senior manufacturing leader to build and run our plastics manufacturing division with end-to-end ownership of a medical and industrial ePTFE (expanded PTFE) production line in South Carolina. You’ll own the strategy, the team, the line, and the numbers—driving P&L, operations, quality, and business development across healthcare and industrial markets.
This is a hands-on, outcomes-driven role for someone who can scale a plant, delight customers, pass audits, and grow a book of business—all at the same time.
What You’ll Do
Division leadership & P&L
Own divisional strategy, operating plan, P&L, and OKRs (OEE, yield, scrap, on-time delivery, CoPQ).
Build and mentor a high-performing team across operations, engineering, quality, and commercial.
Establish a strong safety and compliance culture (EHS/OSHA) and a continuous improvement cadence (Lean/6σ, Kaizen, 5S).
Manufacturing & scale-up (ePTFE)
Stand up and optimize ePTFE processes (e.g., paste extrusion, calendaring, stretching, sintering, skiving) for tubing, sheets, and membranes.
Lead equipment strategy and capital projects—URS/specs, vendor selection, FAT/SAT, commissioning, utilities, and environmental controls.
Lock in robust process windows using DOE, SPC, Cp/Cpk and implement end-to-end genealogy and batch control.
Stand up metrology appropriate for medical and industrial specs (e.g., density, node-fibril microstructure, porosity, tensile, bubble point/air flow).
Quality & regulatory
Implement and maintain compliant QMS for both lines: ISO 13485 & 21 CFR 820 (medical) and ISO 9001 (industrial).
Oversee validations (IQ/OQ/PQ), risk management (FMEA/ISO 14971), DMR/DHR, traceability, CAPA/NCRs, internal/external audits, and data integrity.
Partner with RA/QA on technical files, supplier controls, sterilization compatibility, and biocompatibility testing plans (ISO 10993) as needed.
Supply chain & reliability
Qualify PTFE resins, processing aids, and critical consumables; build multi-source resilience.
Implement S&OP, MRP/ERP discipline, and strong vendor scorecards.
Business development & productization
Own commercial growth for medical and industrial ePTFE: market strategy, pricing, margin mix, and pipeline.
Develop and grow key accounts (OEMs, tier suppliers, filtration/venting/gasketing applications) and channel partners.
Translate voice-of-customer into specs, CTQs, and qualification plans; lead customer tech reviews and audits.
Partner with R&D on next-gen materials and new product introductions.
What You’ve Done
10+ years in polymer/fluoropolymer manufacturing; 5+ years leading plant/line or business unit operations.
Direct experience with ePTFE strongly preferred (PTFE/fluoropolymer expertise required).
Proven success standing up or scaling regulated production lines and passing customer and notified-body/FDA-style audits.
Deep command of process validation (IQ/OQ/PQ), statistics (SPC, DOE), and change control in a medical device context.
Demonstrated P&L ownership and customer-facing growth: pricing, contracts, and key account development.
Comfortable in both shop floor and boardroom.
BS in Chemical Engineering, Materials Science, Mechanical Engineering (or related); MS/MBA a plus.
Nice-to-Haves
Greenfield/transfer experience for ePTFE lines or membranes.
Cleanroom manufacturing (ISO 7/8) and utilities design.
Experience with filtration/venting/industrial applications in addition to medical devices.
ERP (e.g., NetSuite), advanced analytics, or automated in-line inspection implementations.
