Associate Scientist, Drug/Device Combination Products (Onsite) Full-time

Scientist, Device And Combination Product Test 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 a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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:

• A minimum of B.S. plus some experience within design, engineering, and mechanical testing/test method development.
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
• 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, 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

The salary range for this role is $70,500.00 – $110,900.00. 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.

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

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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Regular employment status with no relocation, no visa sponsorship, and no travel requirements. The position is a 1st-day shift.

Required skills include Analytical Chemistry, Biomedical Engineering, Change Catalyst, Clinical Supply Chain Management, Communication, Computer-Aided Design (CAD), EU MDD, Finite Element Analysis (FEA), Global Health, Manufacturing Process Controls, Materials Science, Mechanical Engineering, Mechanical Testing, Medical Devices, Medical Devices Design, Microscopies, Process Engineering, Product Development, Product Testing, Quality Management, Rheometry, Science, Social Collaboration, and more.

Preferred skills are also listed.

Job posting end date is 08/28/2025.