Principal Scientist/Engineer, Drug/Device Combination Products - Device Characterization

Merck • Rahway, NJ

8d • $156,900 - $247,000 • Onsite

About The Position

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

The minimum education requirement is a Ph.D. and at least 8 years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field. The role calls for a record of scientific accomplishment in combination product development, structural finite element analysis, independent laboratory testing and troubleshooting, and expertise with mechanical testing, imaging, and measurement equipment. It also requires experience with 3D CAD, geometric tolerancing and stack-up analysis, FMEA/DFMEA, regulated risk-oriented development, and project leadership involving external vendors or research partners.

The position is based primarily in Rahway, New Jersey. The stated primary-location base salary range is $156,900 to $247,000. The successful candidate may be eligible for an annual bonus and long-term incentive, if applicable. The company describes a comprehensive benefits package that includes healthcare and other insurance, retirement benefits, paid holidays, vacation, and compassionate and sick days.

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 scientific publication and presentation track record.
• Fluency in structural finite element analysis (FEA).
• Ability to test and troubleshoot 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 in 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 layman’s terms to facilitate CMC understanding and support project timelines.
• Development experience in risk-oriented, regulated environments.
• Development project leadership and a proven track record collaborating with and managing external vendors or research partners.

Nice To Haves

• Experience with medical device development 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 appropriate acceptance criteria and sampling plans and ensuring measurement systems analysis for finished-product performance test methods as needed in technology transfer or lifecycle.
• Additional familiarity or experience with 21 CFR Part 4, 21 CFR 211, FDA guidance on container closure systems for packaging human drugs and biologics, ISO 11040, and ISO 10993.

Responsibilities

• Interrogate drug-delivery device technology platforms to identify risks, including how and when devices may fail, and opportunities for improvement.
• Use analytical instruments, methods, and in silico modeling to build understanding of device material and functional properties and attributes.
• Analyze and interpret data to design and develop functional improvements to device platforms and, as opportunities arise, novel delivery technologies.
• 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 or research partners.
• Apply design verification strategies and mechanical testing, including selection of acceptance criteria and sampling plans, where applicable.
• Ensure measurement systems analysis for finished-product performance test methods as needed in technology transfer or lifecycle activities.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree