Product Innovation Engineer

Job Description

Company Summary

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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.

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Position Summary

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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.

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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.

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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.

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

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Duties & Responsibilities

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

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• 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.
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• Experience working within regulated quality systems and product development lifecycle activities is required.
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Education

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Bachelor of Science in Engineering or related scientific discipline

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Certifications/Licenses

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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.

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Other

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