Senior Scientist, Drug/Device Combination Products (Hybrid)
Merck
13 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Job Description
- Hands-on device characterization and design scientist for the Combination Product Characterization and Verification (CPCV) Team.
- Interrogate drug delivery device technology platforms to identify risks (when/how the device fails) and opportunities for improvement.
- Use analytical instruments and methodologies (including in silico modeling) to understand device material and functional properties, focused on intravitreal injection combination product development.
- Collaborate cross-functionally; provide scientific leadership and excellent written/oral communication.
Education Requirement
- B.S., M.S., or Ph.D. in Material Science, Chemistry, or equivalent (required).
Required Experience/Skills
- Minimum: Ph.D. + 4 years, M.S. + 4 years, or B.S. + 6 years in design, engineering, and testing/method development.
- Independent laboratory testing/troubleshooting.
- Strong background in optical imaging, mechanical testing, particle analysis/measurement; including advanced imaging, tensile/compression, surface characterization, x-ray CT, rheometry, microscopy.
- Collaboration/ideation/prototyping; proof-of-concepts, prototypes, functional testing.
- 3D CAD (e.g., SolidWorks), geometric tolerancing & stack-up analysis.
- FMEA/DFMEA fluency.
- Risk-oriented, regulated environment development experience.
- Cross-functional communication; liaise with QA, Analytical Sciences, CROs, etc.
Preferred
- Medical device development with Design Controls (21 CFR 820.30).
- Standards: ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608; plus related knowledge (e.g., 21 CFR Part 4/211, ISO 11040, ISO 10993).
Compensation/Benefits (if applicable)
- Salary range: $117,000.00–$184,200.00; annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, 401(k), paid time off).
Application
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.
- Hands-on device characterization and design scientist for the Combination Product Characterization and Verification (CPCV) Team.
- Interrogate drug delivery device technology platforms to identify risks (when/how the device fails) and opportunities for improvement.
- Use analytical instruments and methodologies (including in silico modeling) to understand device material and functional properties, focused on intravitreal injection combination product development.
- Collaborate cross-functionally; provide scientific leadership and excellent written/oral communication.
Education Requirement
- B.S., M.S., or Ph.D. in Material Science, Chemistry, or equivalent (required).
Required Experience/Skills
- Minimum: Ph.D. + 4 years, M.S. + 4 years, or B.S. + 6 years in design, engineering, and testing/method development.
- Independent laboratory testing/troubleshooting.
- Strong background in optical imaging, mechanical testing, particle analysis/measurement; including advanced imaging, tensile/compression, surface characterization, x-ray CT, rheometry, microscopy.
- Collaboration/ideation/prototyping; proof-of-concepts, prototypes, functional testing.
- 3D CAD (e.g., SolidWorks), geometric tolerancing & stack-up analysis.
- FMEA/DFMEA fluency.
- Risk-oriented, regulated environment development experience.
- Cross-functional communication; liaise with QA, Analytical Sciences, CROs, etc.
Preferred
- Medical device development with Design Controls (21 CFR 820.30).
- Standards: ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608; plus related knowledge (e.g., 21 CFR Part 4/211, ISO 11040, ISO 10993).
Compensation/Benefits (if applicable)
- Salary range: $117,000.00–$184,200.00; annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, 401(k), paid time off).
Application
- Apply via https://jobs.merck.com/us/en. Application deadline is stated on the posting.