Our client, a leader in the medical device industry, is seeking a Senior Process Development Engineer to drive innovation in manufacturing precision coronary catheter devices. This role will be instrumental in refining materials, workstations, components, processes, tooling, and test methods to enhance product reliability, manufacturability, and cost-effectiveness.

Key Responsibilities

• Serve as the liaison between R&D, Product Management, Quality, and suppliers, ensuring product and equipment designs align with Design for Manufacturing/Assembly (DFM/A) principles and Lean Six Sigma methodologies.
• Lead the development, optimization, and implementation of new manufacturing processes and technologies for seamless production transfer.
• Conduct scouting and feasibility studies, selecting materials, equipment, tooling, and fixtures, and assessing alignment with production requirements.
• Drive zero-defect manufacturing by leveraging statistical process control, Poka-Yoke, and predictive maintenance.
• Lead and support design transfer to manufacturing, ensuring efficient and scalable production.

Required Qualifications

• Bachelor’s degree in Mechanical, Electrical, or related Engineering field.
• 10+ years of industry experience, ideally in ISO 13485 or ISO 9001 medical device manufacturing.
• Strong background in collaborating with third-party suppliers and external partners.
• Expertise in statistical methods such as Cpk, ANOVA, Design of Experiments, and GR&R for process development and troubleshooting.
• Deep understanding of equipment concept creation, FAT, IQ/OQ/PQ validation, and software validation.
• Strong technical communication and problem-solving skills, with the ability to work both independently and within a team.