Manufacturing Engineering Manager Job at AVITA Medical Americas, LLC in Ventura

AVITA Medical® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL® System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. We believe that patients are at the heart of everything we do, our employees are the lifeblood of AVITA Medical, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.

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.

The Engineering Manager works with Production Operations, Supply Chain, Facilities, and Quality Control and Assurance to assess and prioritize the work for the engineering team.

Reports to Senior Vice President of Operations

Key Responsibilities:

• Manages all aspects of manufacturing engineering. This includes, but is not limited to,
• Managing day to day engineering aspects of Avita Medical’s 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.

• 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
• Familiar with and experience in medical device manufacturing
• 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

AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.

Your Physical Work Environment Will Require: The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and/or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus. The individual is frequently required to reach with hands and arms, and repetitive motion. The individual is occasionally required to stoop, kneel, or crouch. The individual may occasionally lift and/or move up to 25 pounds.

AVITA Medical is an E-Verify participant.

AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner. AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.