Principal Scientist/Engineer, Drug/Device Combination Products - Device Characterization

In this role, the successful candidate will utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices’ material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies.

These drug delivery device technology platforms can be but not limited to, pre-filled syringes, auto injectors, onbody injectors and inhalers. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.

Education Requirement (minimum)

Ph.D. with 8+ years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field is required.

Required Experience and Skills

• Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a laboratory setting
• Expertise with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Cross-functional communication – communicating complex engineering information in layman’s terms to facilitate CMC cross-functional understanding and to support project timelines.
• Development experience in risk-oriented, regulated environments
• Development project leadership with a proven track record collaborating with and managing external vendors/research partners.

Preferred Experience and Skills

• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
• Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.
• Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
• Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle.
• Additional familiarity/experience with the following knowledge is a plus: 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