Manufacturing Engineer

The Process Development Engineer will lead the design, development, and optimization of manufacturing processes for medical devices in compliance with regulatory standards (ISO 13485, FDA 21 CFR Part 11). This role involves collaborating with cross-functional teams to ensure robust, scalable, and cost-effective processes that meet customer requirements and quality standards.

Duties and Responsibilities

• Develop and validate new manufacturing processes for medical devices, ensuring compliance with regulatory and quality requirements.
• Draft and/or contribute to essential documents (i.e. MPI’s, Inspection Plans, LHR’s, DMR’s, IQ/OQ/PQ Protocols, Process Flow Diagrams, PFMEAs, Control Plans, and Calibration /PM Requirements).
• Initiate process innovation, process development and improvement in terms of cost reduction, yield improvement, and increased efficiencies on catheter product lines.
• Implement Lean and Six Sigma methodologies to reduce variability and improve throughput.
• Coordinate production operations with the requirements for finished products and the need for materials and labor.
• Performs, demonstrates, and trains new employees on all pertinent manufacturing processes and quality requirements.
• Provide technical leadership in the areas assigned and provide “Design for Manufacturing” input to Design Services and customers.
• Design and implement new tooling, fixturing, and capital equipment.
• Work closely with the engineering group to assist and coordinate project transfers from development to production.
• Establish product requirements, prototypes, design and development (including verification and validation), risk assessment, performance and safety testing for new products.
• Maintains detailed documentation throughout all phases of manufacturing development and transfer phases.
• Reviews or coordinates outside vendor activities to support development.
• Interface with customers and internal departments articulating team activities and progress.
• Other duties as assigned.