Sr. Scientist, Drug/Device Combo Products (Onsite)

About the role

This position is responsible for technical interrogation of the various drug delivery device technology platforms supporting the company pipeline to identify risks and opportunities for improvement. The role utilizes a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many platforms are assemblages of injection molded plastic components driving delivery of a drug, typically through mechanical or electro-mechanical means (e.g., injector pens, on-body injectors, inhalers). At early evaluation stages material is often limited, demanding creative approaches.

Responsibilities

• Perform technical interrogation of drug delivery device technology platforms to identify risks and improvement opportunities
• Utilize cutting-edge analytical instruments and methods for extensive data analysis and interpretation
• Build fundamental understanding of device material and functional properties and attributes
• Design, engineer, and develop mechanical testing and test methods
• Troubleshoot independently in a laboratory setting
• Train junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques
• Develop and qualify/validate test methods
• Operate mechanical testing, imaging, and measurement equipment (force/tension/compression testing, rheometry, microscopy, etc.)
• Collaborate, ideate, and prototype, including fixture development for functional testing
• Use 3D CAD (e.g., SolidWorks), geometric tolerancing, and stack-up analysis
• Document and analyze test cases following Good Documentation Practices; provide comprehensive feedback and recommendations for product or design changes
• Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols
• Ensure appropriate selection of acceptance criteria and sampling plans
• Perform measurement systems analysis (MSA) for finished product performance test methods as needed in tech transfer or lifecycle

Requirements

Education: B.S., M.S., or Ph.D. in Mechanical Engineering or equivalent field.

Experience: Minimum of a Ph.D.; or M.S. plus 4 years; or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.

• Exceptional mechanical testing and troubleshooting skills with ability to work independently in a laboratory setting
• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques
• Deep technical understanding of test method development and qualification/validation techniques
• Fluency with mechanical testing, imaging, and measurement equipment and techniques, including force/tension/compression testing, rheometry, and microscopy
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing
• Experience with 3D CAD (e.g., SolidWorks), geometric tolerancing, and stack-up analysis
• Ability to document and analyze test cases following Good Documentation Practices and provide comprehensive feedback and recommendations for product or design changes

Qualifications

• Experience operating and interpreting data from Instron, XRCT, microscopes, vision systems (e.g., Keyence/Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers
• Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans
• Ensure measurement systems analysis (MSA) for all finished product performance test methods as needed in tech transfer or lifecycle
• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
• Familiarity with standards: Quality Management – ISO 13485; Risk Management – ISO 14971; EU MDR; Medical Electrical Equipment – EN 60601; Medical Device Software Standard – IEC 62304; ISO 11608 Needle-based injection system for medical use
• Additional familiarity/experience with: 21 CFR Part 4; 21 CFR 211; FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics; ISO 13485; ISO 14971; ISO 11040; ISO 10993

Skills

Required

• Analytical Method Development
• Component Test
• Creativity
• Design Evaluations
• Design Verification
• Device Design
• External Partners
• Fixtures Design
• Geometric Dimensioning and Tolerancing (GD&T)
• Instron Machine
• ISO 13485 Medical Devices
• Measurement Systems Analysis (MSA)
• Mechanical Design
• Mechanical Testing
• Medical Devices Design
• Method Validation
• Product Analysis
• Product Development
• Prototyping
• Standards Compliance
• Statistical Analysis
• Teamwork
• Technical Evaluation
• Technical Writing

Preferred

• Experience with Instron, XRCT, microscopes, vision systems (Keyence/Cognex), Bouncer, drop shape analyzers, spectrophotometers, rheometers
• Medical device development and Design Controls (21 CFR 820.30)
• ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11