Biomedical Process EngineerKinsey Spahr
Who We Are:
AVITA Medical is a Class III medical device company looking for a full-time IT Systems Specialist to help sustain our expanding line of indications. AVITA is headquartered in Valencia, CA, and manufactures in Ventura, CA. Come join our team and be part of our growth!
What We Are Looking For:
The Biomedical Process Engineer (BPE) is a primary engineering resource for the development of enhancements and improvements to AVITA’s current medical device technology, new platforms and derivative products. This role will be responsible for liaising with the Scientific Affairs team to develop test assays, protocols, and designs for product and process development. The person will also be the main point of contact for transitioning bodies of work from the R&D and process development side to the operations and manufacturing side. The person should have the ability to understand and help mitigate any product risks, evaluating safety and effectiveness, and implementing and executing proper test plans at the various stages of development.
Duties and Responsibilities
- Given our products contain both a mechanical and biological aspect, the BPE shall work closely with our R&D team and engineers to support the biological aspect of the devices.
- The BPE shall be responsible for understanding chemical kinetics, tissue engineering, and the biology of wounds.
- The person shall be responsible for managing projects including budgets and timelines.
- This role will be critical to providing subject matter expertise during root cause analysis and other sustaining activities.
- 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 product requirements.
- 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.
- 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 cell culturing, tissue engineering, enzyme kinetics, and biochemistry.
- Working knowledge and experience with standard laboratory equipment such as spectrophotometers, flow cytometers, pipettes, and pH meters.
- Proficiency in lab report writing and statistical analysis.
Education and Experience
- Minimum Bachelor’s degree in biochemistry, chemical engineering, biomedical science, or other relevant fields. Advanced education preferred.
- 7+ years of 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.
- 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.
- Occasional travel may be required, especially within the Los Angeles and Orange County areas. Generally, no more than 30%.