Manufacturing Line Tech Lead — Medical Devices & NPI

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); Presencial; USD 140 000 - 190 000; Tempo integral

Resumo da oferta

MiniMed is seeking a senior manufacturing engineering lead in Northridge, CA, to guide process validation, equipment readiness, and manufacturing scale-up for new product introductions. You will collaborate across Operations, Quality, Regulatory Affairs, and R&D to drive operational excellence.

The role requires 7+ years in engineering with medical device exposure, a strong background in process optimization and QC systems, and willingness to travel 25-40%.

Qualificações

• Bachelor's degree in Engineering with 7+ years of relevant experience, or Advanced degree in Engineering with 5+ years of relevant experience.
• Experience in medical device manufacturing, process validation, quality systems, and regulatory requirements.
• Experience with cause analysis, statistical methods, and manufacturing process optimization.
• Able and willing to travel for business 25-40% of the time depending on project needs.

Responsabilidades

• Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling.
• Lead new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up.
• Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.
• Lead troubleshooting and resolution of complex manufacturing, equipment, process, and product quality issues.
• Drive continuous improvement initiatives focused on yield enhancement, scrap reduction, cycle-time improvements, and capacity optimization.
• Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
• Mentor and guide manufacturing engineers, process engineers, technicians.

Conhecimentos

Process validation

Statistical methods

Yield optimization

OEE / production efficiency

Travel willingness

Technical escalation

Formação académica

Bachelor's degree in Engineering

Advanced degree in Engineering

Ferramentas

MES

Descrição da oferta de emprego

MiniMed is seeking a senior manufacturing engineering lead in Northridge, CA, to guide process validation, equipment readiness, and manufacturing scale-up for new product introductions. You will collaborate across Operations, Quality, Regulatory Affairs, and R&D to drive operational excellence.

The role requires 7+ years in engineering with medical device exposure, a strong background in process optimization and QC systems, and willingness to travel 25-40%.