Manufacturing EngineerKinsey Spahr
The manufacturing engineer is a technical resource for manufacturing of AVITA Medical products and as an interface with AVITA Medical contract manufacturers and suppliers. The position assures product control documents are current and properly implemented at suppliers. 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.
- Technical and engineering resource to the production of product and components from receipt 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.
- Troubleshooting and problem solving, including root cause analysis.
- Implement corrective and preventive actions for production non-conformances.
- Continuous process monitoring, evaluation, and improvement 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.
- Other duties as assigned
- 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.
This job operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and exposure to Manufacturing Area elements such as noise, dust, odors, and fumes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. Hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m., 40 hours per week.
Occasional travel to vendors will be required, generally less than 10%.
Required Education and Experience
Engineering degree and 5 years of relevant work experience.
Preferred Education and Experience
Advanced engineering degree and 10 years of relevant engineering 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.
Additional Eligibility Qualifications
Work Authorization/Security Clearance
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.