Senior Scientist, Drug/Device Combo Products

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 various drug delivery device technology platforms supporting our pipeline to identify risks (i.e., when/how will the device fail?) and opportunities for improvement.

About the role

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 scientific leadership, and superior written and oral communication abilities.

Responsibilities

• Conduct technical interrogation of drug delivery device technology platforms to identify risks and improvement opportunities.
• Develop a fundamental understanding of device material and functional properties using analytical instruments and in silico modeling.
• Apply advanced imaging techniques, mechanical testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Facilitate design brainstorming sessions, develop proof of concepts, working prototypes, and conduct functional testing.
• Use 3D CAD (e.g., SolidWorks) and perform geometric tolerancing and stack-up analysis.
• Perform Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Liaise closely with partner functions including QA, Analytical Sciences, CROs, and others to support project timelines.
• Communicate complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding.
• Lead development projects in risk-oriented, regulated environments.
• Collaborate with and manage external vendors/manufacturers.

Requirements

• 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 with the ability 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.

Preferred Qualifications

• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with standards: ISO 13485 (Quality Management), ISO 14971 (Risk Management), EU MDR, EN 60601 (Medical Electrical Equipment), IEC 62304 (Medical Device Software), ISO 11608 (Needle-based injection systems).
• Additional familiarity with 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry (Container Closure Systems), ISO 10993, and ISO 11040.

Skills

• Analytical Method Development
• Cross-Functional Collaboration and Communication
• Geometric Dimensioning and Tolerancing (GD&T)
• Mechanical Engineering and Testing
• Method Validation
• Microscopy
• Prototyping
• Quality Management
• Statistical Analysis
• Working with External Partners

Pay

The salary range for this role is $117,000.00 - $184,200.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits

• Comprehensive medical, dental, and vision healthcare for employee and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.
• Annual bonus and long-term incentive (if applicable).

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• 1st shift - Day
• 10% travel required