Manufacturing Engineer

Functional Functional Always active

The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences Preferences

The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

Statistics Statistics

The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

Marketing Marketing

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

Statistics

Store and/or access information on a device, Measure advertising performance, Measure content performance, Understand audiences through statistics or combinations of data from different sources.

Marketing

Store and/or access information on a device, Use limited data to select advertising, Develop and improve services, Use limited data to select content.

Features

Always active

Match and combine data from other data sources, Link different devices, Identify devices based on information transmitted automatically.

Ensure security, prevent and detect fraud, and fix errors, Deliver and present advertising and content.

Functional Functional Always active

The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences Preferences

The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

Statistics Statistics

The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

Marketing Marketing

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

Responsibilities will include, but not be limited to:

• Senior technical resource for processes, systems, and equipment for Manufacturing Engineering elop 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

• 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. Solid Works 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

• 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.