Senior Scientist, Drug/Device Combo Products Full-time

Device Characterization And Design Scientist

Our Company's Combination Product Characterization and Verification (CPCV) Team is seeking a hands-on device characterization and design focused scientist. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. In this role, the successful candidate will leverage a broad range of cutting-edge analytical instruments and methodologies, including in silico modeling, to develop a fundamental understanding of device material and functional properties, with a focus on pre-filled syringe and auto injector combination product development. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.

Education Requirement (minimum):

• B.S., M.S or Ph.D. in Mechanical Engineering, Material Science or equivalent field is required.

Required Experience and Skills:

• A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and testing/test method development experience.
• Solid testing and troubleshooting skills able to work independently in a laboratory setting
• Strong background in optical imaging and mechanical testing, including advanced imaging techniques, tensile and compression testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including facilitating design brainstorming sessions, developing proof of concepts, working prototypes and conducting functional testing.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Liaises closely with other partner functions including QA (Quality), Analytical Sciences, CROs and others to support project timelines.
• Cross-functional communication – communicating complex mechanical engineering information in layman's terms to facilitate cross-functional understanding.
• Development experience in risk-oriented, regulated environments
• Development project leadership with a proven track record collaborating with and managing external vendors/manufacturers.

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, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use.
• Additional familiarity/experience with the following industry related 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

Required Skills:

Analytical Method Development, Cross-Functional Collaboration, Cross-Functional Communications, External Partners, Geometric Dimensioning And Tolerancing (GD&T), Global Health, ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Method Validation, Microscopies, Prototyping, Quality Management, Statistical Analysis

Salary Range for this role is $117,000.00 – $184,200.00