The manufacturing engineer is a technical resource for manufacturing of Avita Medical products and as an interface with Avita Medical contract manufacturers. The position assures product control documents are current and properly implemented at vendors. Designs and recommends processes and equipment for efficient and appropriate manufacturing.
Basic Functions and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Engineering resource for all technical and engineering issues pertaining to the production of product and components from incoming through final inspection.
- Process development and validation
- Tooling and equipment
- Engineering and production documentation
- Ensure product is manufactured in accordance with engineering best practices, Avita’s quality system, international standards and regulations, and specific Avita requirements, particularly FDA QSRs and European MDD/MDR.
- Troubleshooting and problem solving, including root cause analysis and implementing corrective and preventive actions for production non-conformances
- Design transfer for product and process changes, and alternative vendors
- Continuous process monitoring, evaluation, and improvement for increased quality, throughput, reduced lead times, and decreased costs.
- Use Avita’s Document Control system to keep production documentation current and accurate. Ensure integration with contract manufacturers’ systems.
- Support concurrent engineering efforts by participating in design development projects representing operations and engineering, and the customer. Development team duties include product validation, risk management, reliability, etc.
- Design, document and implement methods for process control, process improvement, testing and inspection.
- Participate in change control, material review boards, quality system reviews and operations and engineering representative.
- Evaluate current and prospective suppliers and establish requirements.
- Other duties as assigned
- Competence in engineering skills set (CAD, drawings, manufacturing systems, etc.) and ability to analyze data, identify additional needed information, seek out 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.
This job operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines and exposure to shop elements such as noise, dust, odors and fumes.
Required Education and Experience
Engineering degree and 5 years of relevant work experience as quality engineer, test engineer, etc.
Preferred Education and Experience
Bachelor degree in Engineering or similar field and 10 years quality engineering 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.