Senior Scientist, Combination Product Characterization (Onsite)

MSD Malaysia; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Scientist for hands-on device characterization of combination products (pre-filled syringes and auto-injectors).

You will interrogate device platforms to identify failure modes and opportunities, using analytical instruments, in silico modeling, and cross-functional collaboration with QA, Analytical Sciences, and CROs. In this role, you’ll lead design tests, develop proof-of-concepts, and support project timelines while mentoring staff and

Qualifications

• PhD with 4+ years or MS with 4+ years or BS with 6+ years of design, engineering and testing experience.
• Solid testing and troubleshooting skills in a lab setting.
• Strong background in optical imaging, mechanical testing and imaging techniques.

Responsibilities

• Characterize device technology platforms supporting combination product development.
• Develop tests, methods and proofs of concepts; lead design brainstorming and prototyping.
• Collaborate with QA, Analytical Sciences, CROs and external vendors to meet timelines.

Skills

DFMEA

SolidWorks

X-ray CT

Optical imaging

Prototyping

Mechanical testing

Education

B.S., M.S or Ph.D. in Mechanical Engineering or Materials Science

Tools

SolidWorks

X-ray CT

Rheometer

Microscopy

Job description

Senior Scientist, Combination Product Characterization

Our company's Combination Product Characterization and Verification (CPCV) Team is seeking a hands-on device characterization and design focused scientist. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company;s pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. In this role, the successful candidate will leverage a broad range of cutting-edge analytical instruments and methodologies, including in silico modeling, to develop a fundamental understanding of device material and functional properties, with a focus on pre-filled syringe and auto injector combination product development.

**** Our company in the United States and Canada, 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 and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 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, Material Science 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 testing/test method development experience.
• Solid testing and troubleshooting skills able to work independently in a laboratory setting.
• Strong background in optical imaging and mechanical testing, including advanced imaging techniques, tensile and compression testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Excellent collaboration, ideation, and prototyping skills, including facilitating design brainstorming sessions, developing proof of concepts, working prototypes and conducting functional testing.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Liaises closely with other partner functions including QA (Quality), Analytical Sciences, CROs and others to support project timelines.
• Cross-functional communication – communicating complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding.
• Development experience in risk-oriented, regulated environments.
• Development project leadership with a proven track record collaborating with and managing external vendors/manufacturers.

Preferred Experience and Skills:

• 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 PSCS eligibleforERP

Preferred Skills:

• Analytical Method Development
• Analytical Method Development
• Concept Development
• Conceptualization
• Creativity
• Design Controls
• Design Failure Mode and Effect Analysis (DFMEA)
• Device Control
• Device Design
• External Partners
• Failure Mode and Effects Analysis FMEA
• FMECA
• Geometric Dimensioning And Tolerancing (GD&T)
• IEC 62304
• ISO 13485 Medical Devices
• Manufacturing Processes
• Mechanical Design
• Mechanical Testing
• Medical Devices Design
• Method Validation
• Product Development
• Product Management Leadership
• Prototype Testing
• Prototyping
• Python (Programming Language) {+ 6 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.

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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement 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

Salary range for this role is $117,000.00 - $184,200.00 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employee Status: Regular
Relocation: No relocation
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: 09/28/2026 *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.

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. Employee Status: Regular Relocation: No relocation 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

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 success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.