Sr. Process Development Engineer

Essential Duties and Responsibilities

• Lead design transfer activities from R&D to manufacturing, including development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with FDA QMSR and ISO 13485 requirements
• Perform process optimization through design of experiments and process capability studies
• Engage early in the product design cycle as a manufacturing and process subject matter expert, providing design for manufacturability (DFM) input to development team to reduce downstream transfer risk and accelerate time to production readiness
• Establish standard work and standard equipment operating parameters
• Author, review, and maintain documentation in support of design transfer and process validation; ensure documentation meets Medical Device File requirements
• Demonstrate team leadership with a hands-on approach
• Develop and implement automation solutions
• Troubleshoot equipment problems and develop corrective actions
• Analyze quality problems and develop solutions and improvements
• Ensure adequate engineering studies, design verification, and process validation are completed such that well-characterized, transfer-ready processes are introduced into manufacturing; maintain traceability between process validation outcomes and design inputs
• Coordinate cross-functionally with R&D, Quality, Regulatory, and Operations to ensure complete and compliant product transfers; define and track transfer readiness criteria and milestone deliverables
• May supervise and guide the daily activities of technicians and junior engineers
• Responsible for achieving device manufacturing and engineering operational objectives in support of product performance, process validation, quality, cost and safety

Skills and Qualifications

• BS in Manufacturing, Mechanical, Industrial or Plastics Engineering
• 7+ years experience in an equipment intensive medical device manufacturing environment
• 1-2 years of direct supervisory experience is a plus
• Project management experience is preferred
• Proficient with SolidWorks, with a demonstrated ability to design, prototype, and evaluate fixtures and tooling is a plus
• Experience with plastics processing (extrusion, injection molding, fiber forming) is preferred
• Solid understanding of ISO 13485, FDA QMSR, and design transfer requirements; direct experience writing and executing process validation protocols (IQ/OQ/PQ) is required
• Demonstrated ability to stay organized and implement organizational skills into their team members
• Strong verbal and written communication skills is essential
• Ability to respond to changing priorities and to multi-task, in a dynamic environment

Physical Demands

The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.

About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications.