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

The Combination Product Characterization & Verification group within our Company's Device Development & Technology organization is seeking a hands-on device characterization and design focused technical leader. This position will be responsible for leading the technical interrogation of large volume/on-body, ocular and inhalation delivery systems to identify risks (i.e. when/how will the device fail?) and opportunities for design and process improvements. In this role, the successful candidate will leverage subject material expertise in cutting-edge analytical instruments and methods, including in silico modeling, to lead a team of scientists/engineers to build and drive the fundamental understanding of the devices’ materials/components and their functional properties/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. The successful candidate must have effective cross-functional collaboration skills, demonstrated superior scientific leadership including direct previous mentorship/management, and excellent written and oral communications abilities.

Requirement (minimum): M.S. in Mechanical Engineering or equivalent field with 12+ years of direct (relevant) industry experience. Ph.D. in Mechanical Engineering or equivalent field with 10+ years of direct (relevant) industry experience. Required Experience and Skills: Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record. Expertise in structural finite element analysis (FEA) and in silico modeling. 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. Expertise in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis. Expertise in Design Failure Modes and Effect Analysis (FMEA, DFMEA). Cross-functional communication – communicating complex mechanical engineering and materials science information in layman’s terms to facilitate 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. Direct people management experience. Experience with medical device development with understanding of Design Controls (21 CFR 820.30) 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 Preferred Experience and Skills: Ph.D. in Mechanical Engineering or Materials Science with 12+ years of direct (relevant) industry experience. Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.Additional familiarity/experience with the following knowledge is a plus:21 CFR Part 421 CFR 211FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & BiologicsISO 13485ISO 14971ISO 11040ISO 10993 Required Skills: Animal Vaccination, Biopharmaceutical Industry, Clinical Supply Chain Management, Computed Tomography (CT) Scan, Design Verification Testing, Finite Element Analysis (FEA), Human Factor Engineering, Intellectual Property Management, Mechanical Engineering, Medical Device Design Control, Medical Product Development, Microscopies, Product