Senior Manufacturing Engineer - Medical Devices & Process

ELIXIR MEDICAL CORPORATION; Milpitas (CA); On-site; USD 105,000 - 130,000; Full time

Job summary

Elixir Medical Corporation in Milpitas, CA is seeking a Senior Manufacturing Engineer to lead processes, systems and equipment across Manufacturing Engineering. You will design, optimize and scale manufacturing capabilities, driving quality, capacity and cost improvements while ensuring regulatory compliance.

You will mentor engineers, manage cross-functional projects, and collaborate with R&D to advance manufacturing processes.

Qualifications

• Minimum 5 years experience in medical device manufacturing engineering.
• Technical project management experience.
• Strong knowledge of processes and systems.
• Experience with TP/TR, IQ/OQ/PQ documentation.
• Statistics and data analysis knowledge.
• Excellent verbal and written communication.
• Advanced Excel and Word; SolidWorks a plus.
• Automation & PLC programming experience (Arduino).
• ERP experience (QAD, Oracle, SAP) a plus.
• Experience with electronic QMS such as Arena a plus.

Responsibilities

• Senior technical resource for processes, systems, and equipment for Manufacturing Engineering.
• Develop ME projects to improve quality, capacity, and cost; lead cross-functional groups.
• Analyze benefits vs investments; manage projects from initiation to on-time, on-budget completion.
• Apply internal and external resources to address ME requirements.
• Mentor junior engineers and technicians.
• Resolve manufacturing equipment issues.
• Work with R&D to develop and optimize manufacturing processes.
• Maintain FDA and ISO compliance for medical device development and manufacturing.
• Ensure training and documentation requirements are met.

Job description

Elixir Medical Corporation in Milpitas, CA is seeking a Senior Manufacturing Engineer to lead processes, systems and equipment across Manufacturing Engineering. You will design, optimize and scale manufacturing capabilities, driving quality, capacity and cost improvements while ensuring regulatory compliance.

You will mentor engineers, manage cross-functional projects, and collaborate with R&D to advance manufacturing processes.