Product/Process Development EngineerRay Bauer
The Product/Process Development Engineer is a primary engineering resource for the development of enhancements and improvements to AVITA’s current technology, new platforms and derivative products. This role will be responsible for ensuring that the requisite design controls are in place for all product development activities, from concept through design transfer. Additionally, the Engineer will be responsible for completion of all phases of the product development lifecycle as well as understanding and mitigating any product risks, evaluating safety and effectiveness, and implementing and executing proper test plans at the various stages of development. This role is primarily responsible for the underlying design history file for any product developed as well as for supporting sustaining engineering and continuous improvement activities.
Duties and Responsibilities
- Designs and develops new products, product improvements and line extensions in accordance with corporate objectives.
- Manages projects including ensuring design, deliverables and documentation are performed to requirements while on schedule and within budget.
- Leads DFM activities with suppliers to create robust designs capable of high-volume manufacturing.
- Develops and executes test protocols to ensure product safety and efficacy.
- Works within a cross-functional team and provides oversight of third-party vendors and service providers such as design firms and test laboratories.
- Collaborates with Marketing, Medical Affairs, Scientific Affairs, and others to document user and product requirements.
- Designs, documents and implements methods for production as necessary to support new products or product improvements.
- Designs experiments (DOE) and analyzes data to present to regulatory bodies. Works with internal stakeholders and CROs to execute GLP studies.
- Support various Quality and Regulatory activities such as audits, preventative and corrective actions, etc.
- Root cause analysis of design issues to ensure adherence to the Quality Management System.
- Work with Project Management to coordinate testing activities and ensure on-time submission of design projects.
- Reviews Engineering Change Notifications, engages in internal and third-party audits, and participates in change control and quality system reviews as product development representative.
- Evaluates suppliers and establishes supplier requirements
- Familiarity with 21 CFR 820 and ISO 13485 and 14971 – design controls and risk management in the medical device space.
- Strong technical background in medical device systems’ engineering, product development workflows, product testing, and manufacturing validation.
- Proficiency in 3D CAD modeling, preferably Solidworks and project scheduling.
- Familiarity with cell culturing and analysis highly desirable.
Education and Experience
- Minimum Bachelor’s degree in relevant engineering or life sciences field (eg biomedical engineering, bioengineering, tissue engineering, molecular and cell biology, etc.). Advanced education preferred.
- 7+ years relevant experience in the medical device or pharmaceutical industry. Additional education may substitute for work experience.
- Strong foundation in medical device development.
- Scientific understanding of soft tissue injuries and/or dermatological diseases preferred.
- Engineering competence in design and electro-mechanical engineering.
- Ability to analyze data, identify additional needed information, seek out root cause and offer solutions to problems.
- Attention to detail while maintaining grasp of project goals.
- Familiar with all aspects of medical device Quality Systems.
- Proficient in communication and working with teams that consist of diverse personnel and scattered locations.
- Solid understanding of Design Controls and Risk Management (ISO 13485, 21 CFR 820 and ISO 14971).
- Must have good written and oral communication skills to successfully work with internal team members as well as external suppliers and partners.
- Must be able to work independently as well as a member of a cross-functional team to meet project deadlines.
Ambitious and self-starter. Ability to work in a constantly changing environment.