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

We are seeking a hands-on device characterization and design-focused technical leader to join the Combination Product Characterization & Verification group within our Device Development & Technology organization. This role will lead the technical interrogation of large volume/on-body, ocular, and inhalation delivery systems to identify risks and opportunities for design and process improvements.

About the role

The successful candidate will leverage expertise in cutting-edge analytical instruments and methods, including in silico modeling, to lead a team of scientists and engineers. This role involves building a fundamental understanding of device materials/components and their functional properties/attributes, combined with extensive data analysis/interpretation, to design and develop functional improvements for these platforms. Additionally, the role will drive the development of new and novel delivery technologies as opportunities arise.

Responsibilities

• Lead technical interrogation of combination product delivery systems (large volume/on-body, ocular, inhalation) to identify risks and opportunities for design and process improvements.
• Apply expertise in structural finite element analysis (FEA) and in silico modeling to evaluate device performance.
• Utilize mechanical testing, imaging, and measurement techniques, including mechanical testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Develop and refine 3D CAD models (e.g., SolidWorks) and perform geometric tolerancing and stack-up analysis.
• Conduct Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Communicate complex mechanical engineering and materials science concepts in layman’s terms to facilitate cross-functional understanding.
• Lead development projects in risk-oriented, regulated environments, collaborating with and managing external vendors/research partners.
• Provide direct mentorship and management to a team of scientists and engineers.
• Ensure compliance with Design Controls (21 CFR 820.30) and familiarity with Design Verification (DV) strategies, including engineering studies, validation protocols, and stability studies.
• Oversee measurement systems analysis (MSA) for finished product performance test methods during tech transfer or lifecycle management.

Requirements

• M.S. in Mechanical Engineering or equivalent field with 12+ years of direct (relevant) industry experience, or Ph.D. in Mechanical Engineering or equivalent field with 10+ years of direct (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-technical stakeholders.
• Development experience in risk-oriented, regulated environments (e.g., medical device development).
• Direct people management experience.
• Understanding of Design Controls (21 CFR 820.30) and familiarity with Design Verification (DV) strategies and mechanical test validations.

Preferred Qualifications

• Ph.D. in Mechanical Engineering or Materials Science with 12+ years of direct (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 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. The successful candidate will also be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive medical, dental, and vision healthcare coverage (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

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