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. This role will drive technical interrogation of drug delivery device technology platforms supporting our pipeline, identifying risks (e.g., when/how the device will fail) and opportunities for improvement. You will leverage cutting-edge analytical instruments and methods—including in silico modeling—to build fundamental understanding of device material and functional properties. Through extensive data analysis and interpretation, you will design functional improvements for existing platforms and develop new, novel delivery technologies. Our drug delivery platforms include, but are not limited to, pre-filled syringes, auto-injectors, on-body injectors, and inhalers.

The successful candidate will collaborate cross-functionally, demonstrate scientific leadership, and possess superior written and oral communication skills. Our company is a global healthcare leader with a portfolio of prescription medicines, vaccines, and animal health products, committed to achieving new milestones in global healthcare through innovation and research-intensive biopharmaceutical development.

Responsibilities

• Utilize advanced analytical instruments and methods (e.g., in silico modeling, mechanical testing, imaging, measurement techniques) to characterize drug delivery device material and functional properties.
• Identify risks and opportunities for improvement in device technology platforms through technical interrogation and data analysis.
• Design and develop functional improvements for existing drug delivery platforms and innovate new delivery technologies.
• Apply structural finite element analysis (FEA) and 3D CAD (e.g., SolidWorks) for device design and geometric tolerancing/stack-up analysis.
• Conduct Design Failure Modes and Effect Analysis (DFMEA) to mitigate risks in device development.
• Lead development projects in risk-oriented, regulated environments, collaborating with and managing external vendors/research partners.
• Communicate complex engineering information in accessible terms to cross-functional teams (e.g., CMC) to support project timelines.
• Develop and execute Design Verification (DV) strategies, including mechanical tests, validation protocols, stability studies, and measurement systems analysis (MSA).
• Ensure compliance with relevant standards (e.g., ISO 13485, ISO 14971, EU MDR, ISO 11608) and regulatory requirements (e.g., 21 CFR 820.30, 21 CFR Part 4, 21 CFR 211).

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 3D CAD (e.g., SolidWorks).
• Expertise in mechanical testing, imaging, and measurement techniques (e.g., mechanical testing, surface characterization, X-ray computed tomography, rheometry, microscopy).
• Experience with geometric tolerancing, stack-up analysis, and Design Failure Modes and Effect Analysis (DFMEA).
• Ability to work independently in a laboratory setting with strong troubleshooting skills.
• Development experience in regulated environments (e.g., medical devices, pharmaceuticals).
• Proven project leadership, including collaboration with and management of external vendors/research partners.

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 FDA guidance for container closure systems, ISO 13480, ISO 10993, and 21 CFR Part 4/211.

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 programs, if applicable.

Benefits

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