Principal Research Scientist I Eng - Design Verification Engineer

Role Summary

The Principal Research Scientist I Eng - Design Verification Engineer will lead programs in the development of robust drug delivery systems at the intersection of engineering and biopharmaceutics, and improve capabilities within state-of-the-art laboratories. You will independently conceive, execute, and communicate multi-disciplinary development strategies to achieve project and area goals, working with a global team of scientists, engineers, and leaders on a range of drug delivery systems from autoinjectors to advanced electromechanical infusion pump systems.

Responsibilities

• Define verification strategy and lead planning and execution of the activities to meet program objectives. Create verification plans, protocols, records, and reports. Determine sample size strategy based on strong scientific rationale conforming to internal and regulatory guidelines.
• Lead verification activities within cross-functional teams.
• Lead execution of test procedures and writing of protocols supporting engineering testing and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Experience using Zwick and flow measurement equipment is preferred. Familiarity with 3D printing, CT Scanners, Viscometers, Climate Chambers, etc. is a plus.
• Lead root cause investigations and issue resolutions.
• Define, develop, and validate test methods.
• Implement new testing approaches for state-of-the-art testing & verification.
• Drive global harmonization of development & verification processes.

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience required. (A degree in an engineering field, preferred: mechanical, materials, packaging, bioengineering).
• Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
• Significant background in engineering testing and analysis including:
  • Direct experience of test equipment validation (IQ, OQ, PQ) is required.
  • Expertise in statistical analysis.
  • Significant documentation experience including SOPs, technical reports, and design verification plans/protocols/reports. Expertise with ELN and Design History File tools such as Polarion/LinkUs.
• Proficiency in MS Office, SolidWorks, MATLAB, LabView, Minitab.
• Lean Six Sigma, 5S experience desired.
• Good communication skills, both written and oral. Ability to prepare technical reports and presentations. Demonstrated scientific communication and presentation skills, including the ability to present to senior management.
• Willingness and ability to travel both domestic and internationally, up to 10% of the time.

Skills

• Design Verification for Medical Devices
• Engineering testing and data analysis
• Regulatory compliance (21 CFR 820, MDR)
• Statistical analysis
• Documentation and reporting
• Test equipment validation (IQ/OQ/PQ)
• ELN and Design History File tools (Polarion/LinkUs)

Education

• Bachelor’s degree required; advanced degree preferred in mechanical, materials, packaging, or bioengineering.