Manufacturing Engineer

3 days ago

Reston, Virginia, United States AVITA Medical Full time
Job Title: Manufacturing Engineer

AVITA Medical is seeking a highly skilled Manufacturing Engineer to join our team. As a technical resource for product manufacturing, you will be responsible for ensuring product control documents are current and properly implemented at suppliers.

Key Responsibilities:

  • Design and recommend processes and equipment for efficient and appropriate manufacturing.
  • Ensure product is manufactured in accordance with engineering best practices, Avita's quality system, international standards and regulations, and specific Avita requirements.
  • Troubleshoot and solve problems, including root cause analysis.
  • Implement corrective and preventive actions for production non-conformances.
  • Continuously monitor, evaluate, and improve processes for quality, efficiency, and costs.
  • Use Avita's Document Control system to keep production documentation current and accurate.
  • Support concurrent engineering efforts by participating in design development projects.
  • Design, document, and implement methods for process control, process improvement, testing, and inspection.
  • Lead Design and Tech transfer projects for product and process changes, including qualifying alternate suppliers.
  • Participate in change control, material review boards, quality system reviews as the engineering representative.
  • Evaluate current and prospective suppliers and establish requirements.

Requirements:

  • Engineering degree and 5 years of relevant work experience.
  • Medical Device Sterile Packaging and Sterilization experience.
  • Proven success in working with and improving medical device operations. Knowledge of both FDA QSR and ISO standards.
  • Competence in engineering skills set (CAD, drawings, manufacturing systems).
  • Ability to analyze data, identify additional needed information, determine root cause, and offer solutions to problems.
  • Attention to details and all aspects of medical device quality.
  • Proficient in communication and working with teams that consist of diverse personnel and scattered locations.

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 needs.

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 is 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.

Information Security Compliance:

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.

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