R&D Engineer Stability & Packaging Design

Position Summary / Objectives

The Research & Development Engineer, Stability & Packaging Design, will be primarily responsible for leading product stability/shelf-life studies and packaging design, development, and validation for implantable regenerative technology products. This individual will serve as the internal resource for packaging and shelf-life expertise across projects, ensuring product performance, regulatory compliance, and successful commercialization. The ideal candidate has hands-on experience with packaging design, stability testing, and relevant design software, with the ability to collaborate cross-functionally to support broader R&D efforts. The successful candidate will possess a high degree of professionalism, maturity, and confidentiality.

Essential Job Functions:

• Lead the design, planning, and coordination of product stability and shelflife studies, including protocol development, execution, data analysis, and regulatorycompliant reporting
• Serve as the primary resource for packaging design, development, and validation activities across projects, ensuring packaging supports product stability, sterility, safety, and regulatory requirements
• Utilize packaging design software and CAD tools to create, evaluate, and document packaging concepts and specifications
• Collaborate with crossfunctional teams (Integration, Marketing Quality, Regulatory, and Manufacturing) to integrate packaging and stability requirements into overall product development plans
• Assess, qualify, and monitor packaging materials and configurations to support stability claims, shipping, and storage requirements
• Support verification and validation testing of packaging systems in accordance with ISO, ASTM, and ICH guidelines
• Maintain and oversee quality records and documentation related to stability studies and packaging evaluation
• Write, review, and update protocols, reports, and procedures related to packaging and shelflife activities
• Work with external vendors, suppliers, and consultants to ensure packaging and stability deliverables are met on schedule and within requirements.
• Provide technical input and guidance on packaging and stability for new product development and product improvement projects
• Support broader R&D efforts, including troubleshooting technical challenges during prototyping, validation, and technology transfer as needed.
• Assist with training internal personnel on packaging and stabilityrelated processes.
  
  

Competencies:

• Determination
• Integrity
• Creativity
• Collaboration
• Moved by Urgency
  
  

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing job duties, the employee is occasionally required to stand, walk, sit, use hands to handle or feel objects, tools, or controls, reach with hands and arms, climb stairs, and talk or hear. The employee must occasionally lift or move office products and supplies up to 50 pounds.

Education, Experience, and Certifications:

• Bachelor’s degree in Engineering, Materials Science, Packaging Science, or related field
• 25 years of experience in medical device or biotech product packaging and/or stability studies
• Handson experience with packaging design software (e.g., ArtiosCAD, SolidWorks, AutoCAD, or equivalent)
• Familiarity with ISO 11607, ASTM packaging standards, and ICH stability guidelines
• Knowledge of sterile packaging, barrier materials, and package integrity testing preferred
• Strong organizational skills with the ability to manage multiple studies and projects simultaneously
• Excellent communication and documentation skills for crossfunctional collaboration and regulatory reporting
  
  

Other Duties as Required:

Please note: This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.

• Regenity offers a comprehensive rewards package: o Company performance bonus eligible
• 401(k) plan with company contribution o Paid time off and holidays
• Medical, Rx, dental and vision insurance o Company paid life and AD&D insurance
• Wellness and Employee Assistance Program (EAP) o Tuition Reimbursement
• Salary Range: $70,000 - $90,000 per year
  
  

Regenity Biosciences is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. Regenity Biosciences celebrates the diversity of our team and believes that talent, drive, and experience are the only relevant criteria in evaluating new team members.