Senior Manufacturing Engineer

Meet is partnered with a medical device company based in San Diego County is seeking an experienced Senior Manufacturing Engineer to join their process development and manufacturing team. This company is at the forefront of developing cutting-edge electrophysiology technologies aimed at treating cardiovascular diseases.

Key Responsibilities:

• Develop and optimize manufacturing processes for both new and existing medical devices.
• Collaborate with global suppliers to analyze and define their manufacturing techniques, equipment, and tooling/fixtures to ensure consistent, high-quality products.
• Conduct characterization studies, Design of Experiments (DoE), and perform validation/verification of manufacturing processes and inspection methods (IQ, OQ, PQ).
• Prepare and manage manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF documents.
• Lead a team of engineers and technicians in supporting manufacturing activities.
• Drive innovation in the design and development of manufacturing processes, procedures, tooling, and automation solutions.

Required Qualifications:

• Bachelor's Degree in Engineering (Mechanical, Biomedical, or a related field).
• 5-8 years of experience as a process or manufacturing engineer in the medical device industry.
• Hands-on experience in the manufacturing of Class II or III medical devices.
• Experience in designing fixtures and tooling.
• Previous experience working in a fast-paced startup environment is preferred.
• Proficient in creating technical manufacturing documentation, such as work instructions, forms, BOMs, routers, FMEAs, DMRs, and DHF files.
• Strong understanding of medical device Quality Management Systems, design controls, and product development workflows.
• Experience with SolidWorks or other CAD software.

Work Authorization Requirements:

This position is open to candidates who are already authorized to work in the U.S. and do not require visa sponsorship or visa transfers (e.g., H-1B, L-1, etc.). We are unable to support work visa applications or transfers for this role at this time.