What are the responsibilities and job description for the Senior Product Development Engineer position at Origin Biologics?
Company Summary
At Origin Biologics, our mission is to provide the highest quality orthopedic implants to restore, repair, and regenerate the biological and mechanical functionality lost due to degenerative disease and trauma. As part of the EBOS Group, a leading healthcare player across Australia and New Zealand, we’re backed by over a century of innovation and success. Following EBOS’ 2022 acquisition of Life HealthCare, Origin Biologics has expanded its reach and influence, becoming part of a dynamic, patient-focused network of healthcare companies. With EBOS being the largest and most diversified distributor of healthcare, medical, and pharmaceutical products in Australasia, our resources and global presence offer unparalleled growth opportunities.
Position Summary
The Senior Product Development Engineer supports all aspects of the design, execution and interpretation of process and product development and validation studies for HCT/P’s and medical devices. This includes leading or supporting new product development initiatives, validation, technology transfers, process improvements, and optimization projects. The incumbent will also participate in ongoing strategic initiatives that advance and expand the corporate service portfolio. The role is required to interact with management, other members of the staff, suppliers, third-party laboratories, customers, and manufacturers. International travel to Australia to liaise with Research and Engineering team will be periodically required.
Reasonable Accommodations Statement:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential functions.
Function Responsibilities
- Develop and manage project plans and timelines within the scope of new product development guidelines.
- Provide key technical engineering support to projects and other functions of the company.
- Project planning including budgeting, design inputs, design outputs, design verification, design validation, and design transfer to production.
- Identify and design performance requirements for allograft, medical device, and instrumentation systems.
- Lead process risk analysis activities (FMEA) to support new and existing products and processes
- Development of verification and validation protocols and completion of design verification studies.
- Establish acceptance criteria’s, perform data analysis, and generate final reports.
- Write new, review, and revise existing QMS documentation, such as policies procedures, and forms.
- Development of concept designs and coordination of prototype manufacture.
- Identify, coordinate, and execute engineering change requests.
- Ensure products adhere to company and industry quality standards and regulations.
- Enter cleanroom periodically to qualify and audit processes.
- Develop training plans and facilitate technician training
- Perform investigations and root cause analysis for non-conformances and implement CAPA’s.
- Any other ad hoc duties and projects critical to engineering and the organization.
Qualifications
- Bachelor’s degree in Engineering or a related scientific discipline (biomedical, chemical, or mechanical engineering preferred)
- 4 years of engineering experience; medical device, biologics, or tissue banking experience is a plus
- Experience with CAD or related software
- Knowledge of technical operations, risk management, product development, and technology transfer
- Experience with validation (equipment, methods, processes) and aseptic techniques
- Understanding of GLP, GMP, USP, ISO standards, FDA 21 CFR, ISO 13485, and AATB requirements
- Familiarity with sterilization methods (steam, gamma, or electron beam)
- Experience communicating with customers and working in a manufacturing environment