Sr. Scientist, Drug/Device Combo Products (Onsite)

Merck; Rahway (NJ); Sur place; USD 117 000 - 184 000; Plein temps

Avantages offerts par ce poste

Annual bonus and long-term incentive

Comprehensive benefits package

Résumé du poste

Merck is seeking a highly skilled engineer to interrogate drug delivery device platforms, identify risks, and guide improvements. The role requires extensive mechanical testing, data analysis, and method development using instruments like Instron, XRCT, microscopes, and vision systems.

You will design fixtures, perform GD&T analyses, and ensure compliant documentation. You will work with a diverse team to advance device technologies—from injector pens to on-body injectors—across development

Qualifications

• PhD with MS+4 years or BS+6 years in design, engineering, and mechanical testing experience.
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.
• Deep technical understanding of test method development and qualification/validation techniques.
• Fluency with mechanical testing, imaging, and measurement equipment and techniques.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience in 3D CAD (SolidWorks), geometric tolerancing and stack-up analysis.
• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Responsabilités

• Interrogate the various drug delivery device technology platforms to identify risks and opportunities for improvement.
• Utilize analytical instruments and data analysis to build understanding of material and functional properties and attributes.
• Develop and qualify test methods and support design verification, tech transfer, and lifecycle activities.
• Collaborate with cross-functional teams and develop fixtures for functional testing.
• Document test results and provide feedback and recommendations for product or design changes.

Connaissances

Mechanical testing

Design evaluations

GD&T

Prototyping

3D CAD (SolidWorks)

Data analysis & statistics

Documentation practices

Team collaboration

Formation

B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field

Outils

Instron testing equipment

XRCT

Microscopes

Vision systems (Keyence/Cognex)

Bouncer

Drop shape analyzer

Spectrophotometers

Rheometers

Description du poste

Job Description

Role Summary:

This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company, pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically though mechanical or electro-mechanical means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Education Requirement:

• B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.

Required Experience and Skills:

• A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.

• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.

• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.

• Deep technical understanding of test method development and qualification/validation techniques.

• Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.

• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.

• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.

• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Preferred Experience and Skills:

• Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers.

• Develop innovative 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.

• 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, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use.

• Additional familiarity/experience with the following industry related knowledge is a plus:

• 21 CFR Part 4

• 21 CFR 211

• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics

• ISO 13485

• ISO 14971

• ISO 11040

• ISO 10993

Required Skills:

Analytical Method Development, Analytical Method Development, Component Test, Creativity, Design Evaluations, Design Verification, Device Design, External Partners, Fixtures Design, Geometric Dimensioning And Tolerancing (GD&T), Instron Machine, ISO 13485 Medical Devices, Measurement Systems Analysis (MSA), Mechanical Design, Mechanical Testing, Medical Devices Design, Method Validation, Product Analysis, Product Development, Prototyping, Standards Compliance, Statistical Analysis, Teamwork, Technical Evaluation, Technical Writing {+ 2 more}

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$117,000.00 - $184,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/A

Job Posting End Date:

10/31/2026

***A job posting is effective until 11:59:59PM on the day** BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R423005