Senior Scientist, Drug​/Device Combo Products

Job Description

Our Company's Combination Product Characterization and Verification (CPCV) Team is seeking a hands‑on device characterization and design focused scientist. The role is responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify risks and opportunities for improvement. The successful candidate will leverage a broad range of 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.

Strong cross‑functional collaboration, scientific leadership, and superior written and oral communication skills are required.

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

• 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 lay‑man’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.

• 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 industry related knowledge: 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.

• 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
• Micros copies
• Prototyping
• Quality Management
• Statistical Analysis

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement.

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