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

Job Description

The Combination Product Characterization & Verification group within our Company's Device Development & Technology organization is seeking a hands-on device characterization and design focused technical leader. This position will be responsible for leading the technical interrogation of large volume/on-body, ocular and inhalation delivery systems to identify risks (i.e. when/how will the device fail?) and opportunities for design and process improvements. In this role, the successful candidate will leverage subject material expertise in cutting-edge analytical instruments and methods, including in silico modeling, to lead a team of scientists/engineers to build and drive the fundamental understanding of the devices' materials/components and their functional properties/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. -The successful candidate must have effective cross-functional collaboration skills, demonstrated superior scientific leadership including direct previous mentorship/management, and excellent written and oral communications abilities.

Education Requirement (minimum):

• M.S. in Mechanical Engineering or equivalent field with 12+ years of direct (relevant) industry experience.
• Ph.D. in Mechanical Engineering or equivalent field with 10+ years of direct (relevant) industry experience.

Required Experience and Skills:

• Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record.
• Expertise in structural finite element analysis (FEA) and in silico modeling.
• Expertise with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
• Expertise in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
• Expertise in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
• Cross-functional communication - communicating complex mechanical engineering and materials science information in layman's terms to facilitate 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.
• Direct people management experience.
• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
• 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

Preferred Experience and Skills:

• Ph.D. in Mechanical Engineering or Materials Science with 12+ years of direct (relevant) industry experience.
• Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU MDR, ISO 11608 Needle-based injection system for medical use.Additional familiarity/experience with the following knowledge is a plus:21 CFR Part 421 CFR 211FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & BiologicsISO 13485ISO 14971ISO 11040ISO 10993

Required Skills:
Animal Vaccination, Biopharmaceutical Industry, Clinical Supply Chain Management, Computed Tomography (CT) Scan, Design Verification Testing, Finite Element Analysis (FEA), Human Factor Engineering, Intellectual Property Management, Mechanical Engineering, Medical Device Design Control, Medical Product Development, Microscopies, Product Lifecycle Management (PLM), Project Leadership, Quality Management, Risk Management, Technical Writing

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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:

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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.

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The salary range for this role is
$173,200.00 - $272,600.00

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 .

You can apply for this role through (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

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

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
08/8/2026
*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: R410475