Engineering Process Manager for Medical Device Manufacturing

4 days ago


Ventura, California, United States AVITA Medical Americas, LLC Full time
Role Overview

A challenging opportunity exists to join AVITA Medical Americas, LLC as an Engineering Process Manager. In this role, you will oversee all aspects of manufacturing engineering, ensuring the availability and quality of products and components to support sales while adhering to regulatory requirements.

About the Role
  • Lead manufacturing engineering initiatives, including new product introduction, sustaining engineering, process improvements, and process controls.
  • Manage a team of engineers to achieve operational excellence in production facilities.
  • Collaborate with Production Operations, Supply Chain, Facilities, and Quality Control to prioritize work and optimize resource allocation.
  • Reports to Senior Vice President of Operations.
Key Responsibilities:

You will be responsible for:

  • Managing day-to-day engineering activities at AVITA Medical's production facility to ensure sufficient resources for sales, product development, and process enhancements.
  • Ensuring accurate and current documentation for products and processes.
  • Distributing engineering tasks among the team and providing recommendations for process improvements.
  • Cordinating with the Production Manager to guarantee that necessary processes, documentation, and tooling are available to support production.
  • Regularly reporting project and process status to management both formally and informally.
  • Interfacing with Quality Assurance on inspection and participating in Material Review Board (MRB) as needed.
  • Participating in new product development, identifying processes, equipment, and suppliers for new product introduction.
  • Acting as a liaison with suppliers to resolve issues.
  • Evaluating capacity constraints and implementing strategies to scale capacity and meet demand.
Requirements:
  • Bachelor's degree required; focused engineering discipline or equivalent preferred.
  • A minimum of 10 years' experience in engineering, with at least 3 years in technical supervision.
  • Familiarity with medical device manufacturing and experience in engineering and managing technical personnel.
  • Knowledge of 21CFR 820, ISO 13485, Good Manufacturing Practices (GMPs), and Quality System Regulations (QSRs).
  • Sterilization validation knowledge desirable.
  • Effective communication and interpersonal skills for interfacing with various departments and levels of management.
  • Proficiency in MS Office, Solidworks, and Minitab.
Work Environment:

This role requires sitting, talking, hearing, standing, walking, balancing, using hands and fingers to type, handle objects, feel objects, grasp objects, push, and pull. Hand-eye coordination is necessary for operating computers and office equipment. Close vision and ability to adjust focus are also required.

The individual may occasionally lift and/or move up to 25 pounds. This role involves repetitive motion and occasional stooping, kneeling, or crouching.

Salary Range:

We offer a competitive salary range of $145,000 - $180,000 per year, depending on qualifications and experience.

About Us:

AVITA Medical is a regenerative medicine company pioneering 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.

We believe 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.



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