Senior Process Development Engineer

About This Role

This role involves developing and optimizing manufacturing processes for new medical instruments, partnering with R&D, Quality, and other teams to ensure designs are manufacturable and scalable. The engineer will also be responsible for transferring new designs and processes into production, both locally and with international contract manufacturers.

Responsibilities

• Initiate, own, and complete technical projects resulting in new/improved processes for Calyxo products
• Effectively communicate project status, schedule issues, risks, and major decisions across all company disciplines
• Work closely with R&D, Quality, and Manufacturing teams to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability
• Design and develop manufacturing procedures, tooling, and fixtures for sufficient capacity, product quality, process efficiency, and operator safety
• Provide sustaining production line support, including implementing process improvements, troubleshooting equipment, and addressing operator inquiries
• Train and support production personnel during the transition of new products/processes to production, locally and at international contract manufacturers
• Generate and modify high-quality manufacturing process documentation ensuring compliance with established policies and procedures
• Utilize LEAN, Six Sigma, and other best practice tools and principles for problem solving and continuous improvement
• Assist in identifying equipment needs on the production floor and evaluating sourcing options
• Generate and modify component/assembly/equipment drawings using SolidWorks
• Write and execute process and equipment validations (IQ/OQ/PQ)
• Ensure product quality and support regulatory compliance

Requirements

• BS in Engineering or equivalent experience
• 8+ years of experience supporting medical device manufacturing
• Experience in leading highly technical projects in a cross-functional environment
• Experience working in a structured design process (ISO9000 or FDA QSR)
• Knowledge of regulatory approval process and requirements
• Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001
• Excellent computer skills with Microsoft Office and SolidWorks proficiency
• Compliance with relevant county, state, and Federal rules regarding vaccinations

Qualifications

• BS in Engineering or a combination of relevant education and experience
• Minimum of 8 years of experience supporting medical device manufacturing, with desired experience in catheter manufacturing processes

Nice to Have

• Experience with catheter manufacturing processes

Skills

* Required skills

Benefits