Sr. Scientist, Drug​/Device Combo Pdts

Job Description

Our Company's Device Development & Technology (DD&T) Team is seeking a hands‑on, lab‑focused engineer to characterize and test devices (components, sub‑assemblies, full devices) and combination products (drug‑delivery products). The position will conduct technical interrogation of the drug‑delivery device technology platforms supporting our pipeline to identify risks (e.g., when/why/how a device may fail) and opportunities for improvement. The engineer will use cutting‑edge analytical instruments, methods, and data analysis/interpretation to build a fundamental understanding of a device’s material and functional properties.

Platform examples include injector pens, on‑body injectors, and inhalers, often comprised of injection‑molded plastic components and mechanical or electro‑mechanical driving mechanisms.

Our Company is dedicated to being the world’s premier research‑intensive biopharmaceutical company. The research laboratories are a true scientific research facility of tomorrow, leveraging small‑molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes disease treatment. Join us to experience a culture of strong ethics & integrity, diversified experiences, exceptional science, and a passion for improving human health.

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

• Minimum of a Ph.D. or equivalent with four years, or M.S. plus four years, or B.S. plus six years of design, engineering, and mechanical testing/test method development experience.
• Exceptional mechanical testing and troubleshooting skills for independent work in a laboratory setting.
• Experience training junior staff on instrumentation operation and data analysis best practices.
• Deep technical understanding of test method development and qualification/validation/transfer techniques.
• Fluency with mechanical testing, imaging, and measurement equipment such as force, tension, compression testing, rhinometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience in 3D CAD (e.g., Solid Works), geometric tolerancing, and stack‑up analysis.
• Document test cases per Good Documentation Practices, analyze them, and provide comprehensive feedback and recommendations for product or design changes.

• Experience operating and interpreting data from Instron, XRCT, microscopes, vision systems (Keyence/Cognex), bouncer, and drop‑shape analyzers.
• Develop innovative mechanical tests, validations, engineering studies, design verification protocols, stability studies, and validation protocols with appropriate acceptance criteria and sampling plans. Conduct measurement systems analysis (MSA) for finished product performance test methods as needed in tech transfer or lifecycle.
• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608 and related standards.
• Additional familiarity or experience with 21 CFR Part 4, 21 CFR 211, FDA Guidance for Container Closure Systems, ISO 11040, ISO 10993, and ISO 11608.

Accountability, analytical method development, creativity, data analysis, electromechanical engineering, EU MDD, external partners, geometric dimensioning and tolerancing (GD&T), ISO 13485 medical devices, manufacturing processes, mechanical design, mechanical testing, medical devices, medical device design, medical software, method validation, micrometrology, parasitology, product development, prototyping, quality management, rheometry, statistical analysis, and additional relevant skills.

Current Employees apply HERE. Current Contingent Workers apply HERE.

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…