Device Combination Products - Device Characterization

MSD•Rahway, NJ

1d•$156,900 - $247,000

About The Position

The Device Product and Process Development (DPPD) Team is seeking a hands-on, device-characterization- and design-focused technical leader. The role will technically interrogate drug-delivery device technology platforms supporting the company’s pipeline to identify risks, including how and when devices may fail, and opportunities for improvement. Using analytical instruments and methods, including in silico modeling, the successful candidate will build a fundamental understanding of device material and functional properties and attributes. Extensive data analysis and interpretation will support functional improvements to existing platforms and, when opportunities arise, the development of new delivery technologies. Platforms may include pre-filled syringes, auto injectors, onbody injectors, and inhalers. The role requires effective cross-functional collaboration, scientific leadership, and excellent written and oral communication.

Requirements

Ph.D. in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
At least 8 years of industry experience.
Proven scientific accomplishments in combination product development, with a strong publication and presentation record.
Fluency in structural finite element analysis (FEA).
Strong testing and troubleshooting skills, with the ability to work independently in a laboratory setting.
Expertise with mechanical testing, imaging, and measurement equipment and techniques, including mechanical testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
Experience with 3D CAD such as Solidworks, geometric tolerancing, and stack-up analysis.
Fluency in Design Failure Modes and Effects Analysis (FMEA/DFMEA).
Cross-functional communication skills, including explaining complex engineering information in lay terms.
Development experience in risk-oriented, regulated environments.
Development project leadership experience and a proven record of collaboration with and management of external vendors or research partners.

Nice To Haves

Medical device development experience and understanding of Design Controls (21 CFR 820.30).
Familiarity with ISO 13485, ISO 14971, EU MDR, and ISO 11608 for needle-based injection systems for medical use.
Familiarity with design verification strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols.
Familiarity with selecting suitable acceptance criteria and sampling plans and ensuring measurement systems analysis for finished-product performance test methods.
Additional familiarity or experience with 21 CFR Part 4, 21 CFR 211, FDA guidance for industry on container closure systems for packaging human drugs and biologics, ISO 11040, and ISO 10993.

Responsibilities

Characterize and technically interrogate drug-delivery device platforms to identify risks and opportunities for improvement.
Use analytical instruments and methods, including in silico modeling, to understand device material and functional properties.
Analyze and interpret data to design and develop functional improvements to device platforms.
Develop new and novel drug-delivery technologies as opportunities arise.
Collaborate cross-functionally and communicate complex engineering information in accessible terms to support CMC understanding and project timelines.
Lead development projects and collaborate with and manage external vendors and research partners.
Conduct laboratory testing and troubleshooting independently.
Support design verification strategies, mechanical testing, test method validation, stability studies, and validation protocols, including appropriate acceptance criteria and sampling plans.
Ensure measurement systems analysis for finished-product performance test methods as needed during technology transfer or product lifecycle.