Assoc. Scientist, Research Pharmacy Full-time

Device Development & Technology Engineer

Our Company's Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused engineer focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products). This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company's pipeline to identify risks (when/why/how will the device fail) 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 (compress/torsion spring, compressed gas) or electro-mechanical (DC motor and battery driving a gearbox) 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.

Our Company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our Company's Research Laboratories is a true scientific research facility of tomorrow and will take our Company's leading discovery capabilities and world-class small molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment.

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 (minimum):

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

Required Experience and Skills:

• Design, engineering, and mechanical testing/test method development experience.
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
• Familiarity of test method development and qualification/validation/transfer techniques.
• Familiarity 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, and drop shape analyzers.
• 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
• ISO 11608

Required Skills: Accountability, Analytical Thinking, Biochemical Analysis, Biomedical Engineering, Chemical Engineering, Clinical Manufacturing, Creativity, Data Analysis, Dosage Forms, Evaluating New Technologies, Medical Knowledge, Patent Analysis, Pharmaceutical Production, Product Development, Project Reviews, Scientific Research, Teamwork, Technical Problem-Solving

Preferred Skills:

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. 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.

The salary range for this role is $71,900.00 – $113,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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: No

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: 02/20/2026

*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.