Onsite full time in Ventura, CA

Base target $130-150K - there may be some flex for the right candidate

Position Summary:

The Engineering Manager is responsible for manufacturing engineering, including new product introduction, sustaining engineering, process and product improvements, and process controls. Manages the Manufacturing engineering staff to assure availability and quality of products and components to support sales while complying with regulatory requirements.

Key Responsibilities:

• Manages all aspects of manufacturing engineering. This includes, but is not limited to,
• Managing day to day engineering aspects of the production facility to assure sufficient resources to support sales, product development, and process improvements.
• Ensuring product and processes are fully documented and are accurate and current.
• Distributes engineering work and projects among the engineering staff.
• Provides recommendations for process improvements.
• Coordinates with the Production Manager to ensure processes, documentation, and tooling are available as needed to support production.
• Reports to management periodically, both formally and informally, on project and process status.
• Interfaces with Quality Assurance on inspection and participates in MRB as needed.
• Participates in new product development including identifying processes, equipment, and tooling as well as suppliers in support of new product introduction.
• Acts as a resource with suppliers to resolve issues as needed.
• Assess capacity constraints and initiate efforts to scale capacity to meet demand.
• May be required to perform other related duties as required and/or assigned.

Requirements

• A minimum of a bachelor’s degree is required, a focused degree in an Engineering discipline or equivalent is preferred.
• A minimum of 10 years in Engineering experience
• A minimum of 3 years in technical supervision
• Must have recent medical device manufacturing experience
• Experience in engineering and in managing technical personnel
• Knowledge of 21CFR 820, ISO 13485, Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs)
• Sterilization validation knowledge preferred
• Ability to effectively communicate and interface with all departments and levels of management.
• MS Office, Solidworks, Minitab experience