Senior Manufacturing Engineer

AVITA Medical Americas, LLC; San Buenaventura (Ventura) (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in therapeutic acute wound care is seeking a Senior Manufacturing Engineer. In this pivotal role, you will be a technical resource, interfacing with contract manufacturers and suppliers, while leading engineering development and validation activities. Your expertise will help optimize quality and efficiency in manufacturing processes. You will have the opportunity to design innovative solutions and mentor fellow engineers, contributing to a culture of excellence and integrity. Join a team that values passion and quality, and make a meaningful impact in the medical device field.

Qualifications

• 5+ years of experience in medical device operations with knowledge of FDA QSR.
• Proficient in engineering tools and statistical analysis for process development.

Responsibilities

• Design and recommend efficient manufacturing processes and equipment.
• Establish validation strategies for new products and processes.

Skills

Statistical analysis

Problem-solving

Communication skills

Attention to detail

Education

Bachelor’s Degree in Mechanical Engineering

Master’s Degree in Biomedical Engineering

Tools

CAD software

Manufacturing systems

Job description

Description

AVITA Medical is a leading therapeutic acute wound care company delivering transformative solutions. Our technologies optimize wound healing, effectively accelerating 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 AVITA Medical products and acts as an interface with contract manufacturers and suppliers. This role supports engineering development, validation activities, and leads, coaches, and mentors other engineers on technical requirements to optimize quality and efficiency. Additionally, the engineer ensures product control documents are current and properly implemented at suppliers. The role involves designing and recommending processes and equipment for efficient manufacturing and leading the validation and implementation of those processes or equipment.

Key Responsibilities:

1. Understanding of statistics for process development, including sample size selection, data distribution analysis, process capability, Design of Experiments (DOE), and Analysis of Variance (ANOVA).
2. Knowledge of inspection methods and procedures, including Test Method Validation.
3. Strong problem-solving skills with the ability to ask critical questions, even without being the subject matter expert.
4. Collaborate with product development to design and prototype novel manufacturing processes and equipment.
5. Establish and execute validation strategies (IQ/OQ/PQ) for new products, processes, and equipment in compliance with ISO 13485 and FDA regulations.
6. Skilled in fixture design and development, including mechanical design, tolerance analysis, material selection, and CAD-based engineering drawings.
7. Create and maintain manufacturing process instructions, test methods, product drawings, and component specifications.
8. Ensure manufacturing in accordance with engineering best practices, AVITA's quality system, international standards, and specific AVITA requirements.
9. Provide technical support and perform failure analysis for non-conforming components, assemblies, and process defects.
10. Implement corrective and preventive actions for production non-conformances.
11. Monitor, evaluate, and improve processes continuously to enhance quality, efficiency, and cost-effectiveness.
12. Support concurrent engineering efforts within development projects.
13. Design, document, and implement methods for process control, process improvement, testing, and inspection.
14. Participate in change control, material review boards, and quality system reviews as the engineering representative.
15. Provide leadership and coaching to other engineers and operations staff to optimize quality and efficiency.
16. Perform other duties as assigned.

Requirements

1. Proficiency in engineering tools such as CAD, drawings, and manufacturing systems.
2. Ability to analyze data, identify additional information needs, determine root causes, and develop solutions.
3. Attention to detail and a focus on all aspects of medical device quality.
4. Effective communication skills and ability to work with diverse teams across locations.
5. Bachelor’s or Master’s Degree in Mechanical, Biomedical, or Industrial Engineering.
6. Minimum of 5 years of industry experience.
7. Experience with medical device sterile packaging and sterilization.
8. Proven success in medical device operations, with knowledge of FDA QSR and ISO standards, product validation, and introduction.
9. This is a full-time position, 40 hours per week.
10. Travel requirement: approximately 10%.

AVITA Medical is an Equal Opportunity Employer that celebrates diversity and is committed to creating an inclusive environment. Employment decisions are based on qualifications, merit, and business needs.

The physical work environment may require sitting, talking, hearing, standing, walking, balancing, typing, handling, feeling, grasping, pushing, pulling, reaching, stooping, kneeling, crouching, and lifting up to 25 pounds. Reasonable accommodations may be provided for individuals with disabilities.

AVITA Medical is an E-Verify participant and is committed to information security to protect its systems and data.