Principal Scientist – Device Technical and Engineering Lead – Inhalation Programs (Director Equivalent)
Merck
August 06, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Principal Responsibilities
- Provide inhalation subject-matter leadership (dry powder inhalers, nebulized and other respiratory delivery), including device-platform options, compatibility, dose/aerosol characterization strategy, usability, clinical supply readiness, and transition to commercial manufacturing.
- Lead cross-functional device development strategy for inhalation drug-device combination programs from concept through verification/validation and clinical/commercial launch readiness.
- Lead Device Working Groups and Device Development Engineering Core teams to define device design requirements and execute engineering work (performance, stability, emitted dose, APSD, robustness, usability, manufacturability).
- Serve as technical integrator for end-to-end development activities (CDMO/site selection, compatibility, unit operations, engineering design, aerosol testing/analysis, design controls, risk management, inhalation test method development, verification/validation, component manufacture/assembly, and human factors).
- Author/review relevant regulatory submission content (IND/IMPD/NDA/BLA) for device description, design controls, risk management, human factors, aerosol performance, manufacturing, and control strategy.
Qualifications / Requirements
- B.A./B.S. in Pharmaceutical, Science, Biomedical or Engineering + 10+ years combined (bio)pharma, medical device, combination product development (advanced degree preferred).
- 5+ years leadership with device and drug/product/process development including regulatory submissions; inhalation/respiratory or inhalation combination experience strongly preferred.
- 5+ years leadership managing complex device/combination programs and cross-disciplinary teams.
- Deep knowledge of medical device development, design controls, risk management; inhalation device design, requirements, aerosol verification, automation/process development, design validation, human factors, and control strategy.
Required/Preferred Skills
- Aerosol/pulmonary drug delivery, dry powder inhalers (DPI), design controls, risk management/product risk management, human factors engineering, engineering analysis (incl. FEA), manufacturing/process development, medical device quality systems.
Application Instructions / Benefits
- Annual bonus and long-term incentive (if applicable); comprehensive benefits package (medical/dental/vision, 401(k), paid holidays, vacation, sick/compassionate days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting.
- Provide inhalation subject-matter leadership (dry powder inhalers, nebulized and other respiratory delivery), including device-platform options, compatibility, dose/aerosol characterization strategy, usability, clinical supply readiness, and transition to commercial manufacturing.
- Lead cross-functional device development strategy for inhalation drug-device combination programs from concept through verification/validation and clinical/commercial launch readiness.
- Lead Device Working Groups and Device Development Engineering Core teams to define device design requirements and execute engineering work (performance, stability, emitted dose, APSD, robustness, usability, manufacturability).
- Serve as technical integrator for end-to-end development activities (CDMO/site selection, compatibility, unit operations, engineering design, aerosol testing/analysis, design controls, risk management, inhalation test method development, verification/validation, component manufacture/assembly, and human factors).
- Author/review relevant regulatory submission content (IND/IMPD/NDA/BLA) for device description, design controls, risk management, human factors, aerosol performance, manufacturing, and control strategy.
Qualifications / Requirements
- B.A./B.S. in Pharmaceutical, Science, Biomedical or Engineering + 10+ years combined (bio)pharma, medical device, combination product development (advanced degree preferred).
- 5+ years leadership with device and drug/product/process development including regulatory submissions; inhalation/respiratory or inhalation combination experience strongly preferred.
- 5+ years leadership managing complex device/combination programs and cross-disciplinary teams.
- Deep knowledge of medical device development, design controls, risk management; inhalation device design, requirements, aerosol verification, automation/process development, design validation, human factors, and control strategy.
Required/Preferred Skills
- Aerosol/pulmonary drug delivery, dry powder inhalers (DPI), design controls, risk management/product risk management, human factors engineering, engineering analysis (incl. FEA), manufacturing/process development, medical device quality systems.
Application Instructions / Benefits
- Annual bonus and long-term incentive (if applicable); comprehensive benefits package (medical/dental/vision, 401(k), paid holidays, vacation, sick/compassionate days).
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting.