Product Innovation Engineer

Company Summary

Our primary mission is to provide the highest quality orthopedic implants to restore, repair, and regenerate biological and mechanical functionality lost due to degenerative diseases or trauma-related incidents. Origin Biologics, Inc. (OB) is part of the EBOS Group, a publicly listed global healthcare organization.

Position Summary

The Product Development Engineer is responsible for the design, execution, and interpretation of process and product development and validation studies for HCT/Ps and medical devices. This includes supporting new product development, validation, technology transfers, process improvements, and optimization projects.

The Product Development Engineer works in a regulated environment where the responsibilities of this role directly impact product quality, regulatory compliance, and the integrity of products intended for human implantation. This is a safety-sensitive position, and employees in this position are subject to the Company’s Substance Abuse Policy and applicable drug testing requirements.

The role interacts with management, staff, suppliers, third-party laboratories, customers, and manufacturers. International travel to Australia to liaise with the Research and Engineering team will be periodically required.

Candidates must have experience in the medical device, biologics, tissue banking, or a related regulated life sciences industry.

Duties & Responsibilities

• Support project plans and timelines for new product development.
• Provide technical engineering support for projects and other company functions.
• Support project planning, including budgeting, design inputs and outputs, design verification and validation, and design transfer to production.
• Identify and define performance requirements for allograft, medical device, and instrumentation systems.
• Support process risk activities (FMEA) for new and existing products and processes.
• Develop verification and validation protocols and complete design verification studies.
• Establish acceptance criteria, perform data analysis, and generate final reports.
• Write, review, and revise QMS documentation, including policies, procedures, and forms.
• Support concept designs and coordinate prototype manufacture.
• Identify, coordinate, and support engineering change requests.
• Ensure products adhere to company and industry quality standards and regulations.
• Support process qualification and verification activities in cleanroom environments.
• Support training activities for production personnel.
• Perform investigations and root cause analysis for non-conformances and implement CAPAs.
• Perform other duties and projects critical to engineering and the organization.

Experience

• Minimum 3+ years of experience in product development, process development, validation, commercialization, or related activities within the medical device, biologics, tissue banking, pharmaceutical, or related regulated industry.
• Experience working within regulated quality systems and product development lifecycle activities is required.

Education

Bachelor of Science in Engineering or related scientific discipline

Certifications/Licenses

Certifications in a technical discipline relevant to the position (e.G., Certified Quality Engineer, Certified Process Validation Engineer, CTBS Certification) are not required but are considered a plus for candidates with specialized validation or quality systems experience.

Other

• Understand the requirements of FDA 21 CFR, ISO 13485, and AATB standards.
• Understand GLP, GMP, USP, and ISO guidelines and methodologies
• Fundamental knowledge of aseptic techniques and principals
• Experience with equipment/method/process validation design and acceptance criteria
• Experience with handling biohazardous material, including human, biological and chemical samples
• Knowledge of basic sterilization practices using steam sterilization, gamma or electron beam radiation
• Strong technical writing skills and statistical data analysis capabilities