Engineer III, Product Development

Position Summary

Incumbent will guide the design, development, and commercialization of medical devices, biologics, and HCT / Ps to meet requirements of Good Tissue, Manufacturing and Laboratory Practices (GTP / GMP / GLP). The Engineer III will drive the application of Quality by Design (QbD) principles to product and process in biologics development, process optimization, medical device design controls, and risk management. This role is highly cross-functional and requires the use of advanced engineering while interfacing with technical services, manufacturing, quality, donor services, regulatory and commercial teams to translate scientific discoveries into scalable, compliant, and market-ready solutions.

Essential Duties & Responsibilities

• Drive the design and development of products and processes as well as improvements to existing products ensuring scalability and manufacturability.
• Develop and conduct the plan for assigned projects which includes generating prototypes, performing feasibility testing, and refining designs using data-driven approaches.
• Lead design control activities including risk management (e.g., FMEAs, HACCP), verification and validation testing.
• Design validation protocol and conduct qualification of equipment used under GLP and GMP facility.
• Create and maintain design history files, technical drawings, and product specifications in compliance with regulatory requirements (FDA, ISO, GMP).
• Apply QbD principles to product and process development, ensuring systematic identification of critical quality attributes (CQAs), critical process parameters (CPPs), and risk mitigation strategies.
• Develop test methods for device performance and characterization testing as well as execute laboratory studies, feasibility testing, and process development experiments.
• Apply statistical tools for data analysis, product or process characterization, and design of experiments (DOE).

Collaborate with Supply Chain and Quality Assurance in the identification of supplies, supplier and support qualification for GMP activities.

Skills & Abilities

Essential Duty Definition :

Position Expertise / Qualifications

Physical Requirements