Summary: The Sr. Process Development Engineer will provide technical leadership in the innovation, design, development and optimization of new and modified manufacturing processes, tooling and equipment for innovative single use medical devices for therapeutic applications. A core focus of this role is leading the design transfer process — working with a cross functional team during early-phase design to ensure manufacturability, authoring and executing process validation protocols (IQ/OQ/PQ), and providing input on SOPs, work instructions, and Medical Device File documentation required to support successful product design transfers to manufacturing. The position offers the unique opportunity to partake in a growth-stage start-up company with career advancement opportunities. The right individual has process development and design transfer experience from collaboration with quality and operations, brings deep knowledge of process validation requirements under QMSR and ISO 13485, and is eager to face engineering challenges and participate in ongoing process improvements.

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

· Demonstrates 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

· Work with Quality Control to resolve supplier quality issues

· Manage the end-to-end design transfer process, coordinating 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

· Enforce compliance to all Good Manufacturing Practices and Standard Operating Procedures as defined by the Company’s policies, practices and procedures

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.

Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.