Manufacturing Engineer

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

Responsibilities will include, but not be limited to:

• Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir. Develop new processes, optimize existing processes and systems, and design for future requirements
• Develop Manufacturing Engineering projects to improve quality, capacity, and cost. Lead cross-functional stakeholder groups for projects. Analyze benefits vs investment for initiatives. Manage projects and resources from initiation to implementation on-time and on-budget
• Apply internal and external resources to appropriately address Manufacturing Engineering requirements
• Mentor junior engineers and technicians in the organization
• Resolve manufacturing equipment issues
• Work with the R&D team to develop and optimize manufacturing processes
• Maintain compliance with FDA and ISO guidelines for medical device development and manufacturing
• Maintain compliance with all document and procedure training requirements

Qualifications and Skills

• Minimum 5 years relevant experience in medical device industry Manufacturing Engineering (ME); preferably including Class III implants
• Technical project management experience
• Detailed technical knowledge of processes and systems
• Experience with technical writing; TP/TR, IQ/OQ/PQ, etc., with documentation sufficient for regulatory submissions
• Knowledge of Statistics and Data Analysis
• Solid operational project management experience together with the ability to work in a collaborative environment
• Excellent communication, both verbal and written and people skills
• Advanced Excel and solid Word skills. SolidWorks is a plus
• Experience integrating automation stations, programming PLC (Arduino), computer-controlled machinery
• Experience with ERP system such as QAD, Oracle, SAP or similar is a plus
• Experience with electronic Quality Management Systems such as Arena is a plus

Education Requirements

• BS in Engineering discipline, Master’s degree a plus

This position is based in Milpitas, CA and is an onsite position. The salary range is $105K to $130K based on factors including experience, skills, etc.