Sr. Scientist, Drug/Device Combo Products (Onsite)

Job Description

Role Summary:

This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company, pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically though mechanical or electro-mechanical means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Education Requirement:

• B.S., M.S. or Ph.D. in Mechanical Engineering 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 mechanical testing/test method development experience.
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.
• Deep technical understanding of test method development and qualification/validation techniques.
• Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Preferred Experience and Skills:

• Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers.
• Develop innovative 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.
• 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

PSCS

eligibleforERP

Required Skills:

Analytical Method Development, Analytical Method Development, Component Test, Creativity, Design Evaluations, Design Verification, Device Design, External Partners, Fixtures Design, Geometric Dimensioning And Tolerancing (GD&T), Instron Machine, ISO 13485 Medical Devices, Measurement Systems Analysis (MSA), Mechanical Design, Mechanical Testing, Medical Devices Design, Method Validation, Product Analysis, Product Development, Prototyping, Standards Compliance, Statistical Analysis, Teamwork, Technical Evaluation, Technical Writing {+ 2 more}

Preferred Skills:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here 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. …