Senior Principal Scientist/Engineer, Drug/Device Combination Products Characterization

About the role

We are seeking a hands-on device characterization and design-focused technical leader to lead the technical interrogation of large volume/on-body, ocular, and inhalation delivery systems. In this role, you will identify risks (e.g., when/how the device will fail) and opportunities for design and process improvements. Leveraging expertise in cutting-edge analytical instruments and methods—including in silico modeling—you will lead a team of scientists and engineers to build a fundamental understanding of device materials, components, and their functional properties. Through extensive data analysis and interpretation, you will design functional improvements for existing platforms and develop new and novel delivery technologies.

Responsibilities

• Lead technical interrogation of combination products (large volume/on-body, ocular, and inhalation delivery systems) to identify failure risks and design improvement opportunities.
• Apply expertise in structural finite element analysis (FEA) and in silico modeling to drive device characterization.
• Utilize mechanical testing, imaging, and measurement techniques (e.g., mechanical testing, surface characterization, X-ray computed tomography, rheometry, microscopy).
• Develop and refine 3D CAD models (e.g., SolidWorks), geometric tolerancing, and stack-up analysis.
• Conduct Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Communicate complex mechanical engineering and materials science concepts in accessible terms to cross-functional teams.
• Lead development projects in risk-oriented, regulated environments, collaborating with and managing external vendors/research partners.
• Mentor and manage a team of scientists and engineers.
• Ensure compliance with medical device development standards, including Design Controls (21 CFR 820.30).
• Design and execute Design Verification (DV) strategies, including engineering studies, validation protocols, stability studies, and measurement systems analysis (MSA).
• Define appropriate acceptance criteria and sampling plans for verification and validation activities.

Requirements

• M.S. in Mechanical Engineering or equivalent field with 12+ years of relevant industry experience, or Ph.D. in Mechanical Engineering or equivalent field with 10+ years of relevant industry experience.
• Proven record of scientific accomplishments in combination product development, with a strong publication and presentation track record.
• Expertise in structural finite element analysis (FEA) and in silico modeling.
• Hands-on experience with mechanical testing, imaging, and measurement equipment (e.g., mechanical testing, surface characterization, X-ray computed tomography, rheometry, microscopy).
• Proficiency in 3D CAD (e.g., SolidWorks), geometric tolerancing, and stack-up analysis.
• Experience with Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Strong cross-functional communication skills, including the ability to translate complex technical information for non-experts.
• Direct people management and mentorship experience.
• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with Design Verification (DV) strategies, mechanical test validations, and measurement systems analysis (MSA).

Preferred Qualifications

• Ph.D. in Mechanical Engineering or Materials Science with 12+ years of relevant industry experience.
• Familiarity with industry standards: ISO 13485 (Quality Management), ISO 14971 (Risk Management), EU MDR, ISO 11608 (Needle-based injection systems).
• Additional experience with 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry (Container Closure Systems), ISO 13485, ISO 14971, ISO 11040, and ISO 10993.

Skills

• Animal Vaccination
• Biopharmaceutical Industry
• Clinical Supply Chain Management
• Computed Tomography (CT) Scan
• Design Verification Testing
• Finite Element Analysis (FEA)
• Human Factor Engineering
• Intellectual Property Management
• Mechanical Engineering
• Medical Device Design Control
• Medical Product Development
• Microscopies
• Product Lifecycle Management (PLM)
• Project Leadership
• Quality Management
• Risk Management
• Technical Writing

Pay

The salary range for this role is $173,200.00 – $272,600.00. An employee’s position within the range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs.

Benefits

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

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