Principal Scientist/Engineer, Drug/Device Combination Products - Device Characterization
Merck
Summary
The Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused technical leader. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement.
Job description
In this role, the successful candidate will utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices' material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies.
These drug delivery device technology platforms can be but not limited to, pre-filled syringes, auto injectors, on-body injectors and inhalers. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.
Education Requirement (minimum)
Ph.D. with 8+ years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field is required.
Required Experience And Skills
- Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record.
- Fluency in structural finite element analysis (FEA).
- Solid testing and troubleshooting skills able to work independently in a laboratory setting.
- Expertise with mechanical testing, imaging, and measurement equipment and techniques, including but not limited to mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
- Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
- Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
- Cross-functional communication – communicating complex engineering information in layman's terms to facilitate CMC cross-functional understanding and to support project timelines.
- Development experience in risk-oriented, regulated environments.
- Development project leadership with a proven track record collaborating with and managing external vendors/research partners.
Preferred Experience And Skills
- Experience with medical device development with understanding of Design Controls (21 CFR 820.30).
- Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.
- Familiarity with Design Verification (DV) strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
- Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.
- Additional familiarity/experience with 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry Container Closure Systems, ISO 13485, ISO 14971, ISO 11040, ISO 10993.
Requirements
- Ph.D. in Mechanical Engineering, Biomedical Engineering, or an equivalent field
- 8+ years of industry experience
- Proven record of scientific accomplishments in combination product development with strong publication and presentation track record
- Fluency in structural finite element analysis (FEA)
- Solid testing and troubleshooting skills able to work independently in a laboratory setting
- Expertise with mechanical testing, imaging, and measurement equipment and techniques including surface characterization, x-ray computed tomography, rheometry, and microscopy
- Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis
- Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA)
- Cross-functional communication skills
- Development experience in risk-oriented, regulated environments
- Development project leadership with proven track record collaborating with and managing external vendors/research partners
Benefits
- Medical, Dental & Vision
- Other Insurance Benefits
- 401(k) Retirement Benefits
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.