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.
  • Partner with technical services and manufacturing to support technology/knowledge transfer and manufacturing scale-up.
  • Assist in technical writing for regulatory and manuscript submission.     
  • Lead investigations related to nonconformances and CAPAs in applicable functional area and ensure timely closure of records. 
  • Authors and manage standard operating procedures (SOPs), work instructions (WIs) and any other applicable technical documentation.
  • Stay current with new technologies, materials, and industry trends relevant to biotechnology product development.
  • Mentor entry-level engineers or interns.
  • Perform other duties and projects as assigned.

Skills & Abilities

Essential Duty Definition:

• Knowledge of cGMP, design controls, and product development life cycle in regulated environments (e.g., FDA 21 CFR Part 820, Part 210/211, Part 1270/1271, ISO 13485, ICH).
• Strong problem solving and organization skills with attention to detail. 
• Excellent communication skills (oral/written).
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional and cooperative environment.
• Demonstrated ability to lead execution of complex projects and practical application of project management concepts
• Statistical Software Proficiency (Minitab, SPSS or similar).
• 3D Design Software Proficiency (Solidworks or similar).
• Microsoft Office Proficiency (Excel, Word, PowerPoint, Outlook and Visio).

Position Expertise/Qualifications 

• Bachelor’s degree in biomedical engineering, other engineering disciplines, biological sciences or related field, required (Master’s preferred).
• Four  or more years of design/formulation experience in the biotechnology sector with strong fundamental knowledge in GMP.
• Design and development of bioresorbable medical devices.  

Physical Requirements

• Ability to work in laboratory, office, and cleanroom environments. 
• Some travel may be required (<20%)