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

Merck; Rahway (NJ); On-site; USD 180,000 - 260,000; Full time

Job summary

Merck is seeking a hands-on device characterization and design focused technical leader in Rahway, NJ. The role will interrogate drug delivery device platforms, identify risks and improvements, and drive functional enhancements using FEA, in silico modeling, and data analysis across pre-filled syringes, auto-injectors, and inhalers.

The successful candidate will lead cross-functional teams, collaborate with external vendors, and communicate complex engineering concepts clearly to support

Qualifications

• PhD with 8+ years of industry experience in Mechanical, Biomedical or equivalent.
• Proven record of scientific accomplishments in combination product development with publications/presentations.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a lab.
• Expertise with mechanical testing, imaging, and measurement equipment incl. x-ray CT, rheometry, microscopy.
• Experience in 3D CAD (SolidWorks), geometric tolerancing and stack-up analysis.
• Fluency in Design Failure Modes and Effects Analysis (FMEA, DFMEA).
• Cross-functional communication to support project timelines.
• Development in risk-oriented, regulated environments.
• Leadership in development projects with external vendors/research partners.

Responsibilities

• Lead technical interrogation of device technology platforms to identify risks and improvement opportunities.
• Design and develop functional improvements for drug delivery platforms using analytical tools and data analysis.
• Collaborate across cross-functional teams and external partners to advance projects.
• Communicate complex engineering concepts clearly to stakeholders to support timelines and regulatory expectations.

Skills

FEA

Mechanical testing

Imaging

X-ray CT

Rheometry

Microscopy

SolidWorks

DFMEA

Cross-functional comms

Regulated development

Vendor management

Education

Ph.D. in Mechanical/Biomedical Eng

Tools

SolidWorks

Job description

Job Description

The company Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused technical leader. 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 utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices' material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies. These drug delivery device technology platforms can be but not limited to, pre-filled syringes, auto injectors, onbody injectors and inhalers. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.

Our company is a global health care leader with a 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, 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)

• Ph.D. with 8+ years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field is required.

Required Experience and Skills

• Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a laboratory setting
• Expertise with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing, surface characterization, x-xray computed tomography, rheometry, and microscopy.
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack- up analysis.
• Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Cross- functional communication – communicating complex engineering information in layman's terms to facilitate CMC cross- functional understanding and to support project timelines.
• Development experience in risk- oriented, regulated environments
• Development project leadership with a proven track record collaborating with and managing external vendors/research partners.

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, ISO 11608 Needle- based injection system for medical use.
• Familiarity with Design Verification (DV) strategies and 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.
• Additional familiarity/experience with the following 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

Animal Vaccination, Biomedical Engineering, Biopharmaceutical Industry, Combination Products, Design Controls, Finite Element Analysis (FEA), Global Health, Human Factor Engineering, Mechanical Testing, Medical Device Quality Systems, Microscopies, Process Development Engineering, Project Leadership, Quality Management, Quality Standards, Risk Management, Vendor Relationship Management

Additional location(s)

Primary location for this posting is: USA - New Jersey - Rahway

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

Search Firm Representatives Please Read Carefully

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

Flexible Work Arrangements

Not Applicable

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

R410078