Senior Manufacturing Engineer

Description

AVITA Medical is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies optimize wound healing, effectively accelerating the time to patient recovery.

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 Senior Manufacturing Engineer is a technical resource for manufacturing of AVITA Medical products and as an interface with AVITA Medical contract manufacturers and suppliers. This role will support Engineering development, validation activities, and lead coaches and other engineers on technical requirements to help optimize quality and efficiency. Additionally, assure product control documents are current and properly implemented at suppliers. In charge of designing and recommending processes and equipment for efficient and appropriate manufacturing, and lead the validation and implementation of those processes or equipment.

Key Responsibilities

• Working understanding of statistics for process development including sample size selection, data distribution analysis, process capability, Design of Experiments (DOE), and Analysis of Variance (ANOVA).
• Working understanding of inspection methods and procedures (Test Method Validation).
• Demonstrate strong problem-solving skills and have the ability to ask critical questions without being the subject matter expert.
• Work with product development to design and prototype novel manufacturing processes and equipment.
• Establish and execute validation strategies (IQ/OQ/PQ) for new products, processes, and equipment in compliance with ISO 13485 and FDA regulations
• Skilled in fixture design and development, including mechanical design, tolerance analysis, material selection, and CAD-based engineering drawings
• Create and maintain necessary Manufacturing Process Instructions (MP’s), test methods, product drawings, and component specifications
• Ensure product is manufactured in accordance with engineering best practices, AVITA's quality system, international standards and regulations, and specific AVITA requirements.
• Provides technical support and performing failure analysis for non-conforming components, assemblies, and process defects
• Implement corrective and preventive actions for production non-conformances.
• Continuous process monitoring, evaluation, and improvement for quality, efficiency, and costs to prevent issues before they occur.
• Support concurrent engineering efforts within development projects.
• Design, document, and implement methods for process control, process improvement, testing, and inspection.
• Participate in change control, material review boards, quality system reviews as the engineering representative.
• Provide leadership and coaching to other engineers and within operations to optimize quality and efficiency
• Other duties as assigned
  
  

Requirements

• 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.
• Bachelor’s or Master’s Degree in mechanical, Biomedical, or Industrial Engineering.
• 5+ years of equivalent industry 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. Demonstrated knowledge in product validation and introduction.
• This is a full-time position 40 hours per week.
• Travel: Approximately 10%
  
  

EEOC: 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.

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.