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

We are seeking a hands-on device characterization and design-focused technical leader to join our Device Product and Process Development (DPPD) Team. In this role, you will conduct technical interrogation of various drug delivery device technology platforms supporting our pipeline to identify risks and opportunities for improvement. You will utilize cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of devices’ material and functional properties. This role combines extensive data analysis and interpretation with design and development of functional improvements for existing platforms and, when opportunities arise, new and novel delivery technologies.

Our drug delivery device technology platforms may include pre-filled syringes, auto injectors, on-body injectors, and inhalers. The successful candidate must demonstrate effective cross-functional collaboration, excellent scientific leadership, and superior written and oral communication abilities.

Our company is a global healthcare leader with a portfolio of prescription medicines, vaccines, and animal health products. We are committed to being the world’s premier, most research-intensive biopharmaceutical company, doubling down on breakthrough science to radically change how we approach serious diseases.

Responsibilities

• Utilize analytical instruments and methods (e.g., in silico modeling, mechanical testing, imaging, measurement techniques) to assess device material and functional properties.
• Analyze and interpret data to identify risks (e.g., device failure modes) and opportunities for improvement in drug delivery platforms.
• Design and develop functional improvements for existing device platforms and contribute to the creation of new delivery technologies.
• Apply structural finite element analysis (FEA) and Design Failure Modes and Effect Analysis (DFMEA) to evaluate device performance.
• Conduct mechanical testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Use 3D CAD (e.g., SolidWorks) for design, geometric tolerancing, and stack-up analysis.
• Communicate complex engineering concepts in accessible terms to cross-functional teams to support project timelines.
• Lead development projects in risk-oriented, regulated environments, collaborating with and managing external vendors and research partners.
• Ensure compliance with design controls (21 CFR 820.30) and relevant standards (e.g., ISO 13485, ISO 14971, EU MDR, ISO 11608).
• Develop and execute Design Verification (DV) strategies, including engineering studies, validation protocols, stability studies, and measurement systems analysis (MSA).

Requirements

• Ph.D. with 8+ years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
• Proven record of scientific accomplishments in combination product development, with a strong publication and presentation track record.
• Fluency in structural finite element analysis (FEA) and Design Failure Modes and Effect Analysis (DFMEA).
• Hands-on expertise 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 in risk-oriented, regulated environments (e.g., medical device or biopharmaceutical development).
• Demonstrated project leadership, including collaboration with and management of external vendors/research partners.
• Strong cross-functional communication skills to convey complex engineering information clearly.

Preferred Qualifications

• Experience with medical device development and understanding of Design Controls (21 CFR 820.30).
• Familiarity with quality and risk management standards: ISO 13485, ISO 14971, EU MDR, ISO 11608.
• Experience with Design Verification (DV) strategies, including engineering studies, validation protocols, stability studies, and measurement systems analysis (MSA).
• Knowledge of additional regulations and guidance: 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry on Container Closure Systems, ISO 13485, ISO 14971, ISO 11040, ISO 10993.

Pay

The salary range for this role is $156,900.00 - $247,000.00. An employee’s position within the range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, and business needs. The successful candidate will 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, compassionate leave, and sick days.