Merck
Associate Principal Scientist/Engineer, Medical Device and Combination Products,
Merck, Lansdale, Pennsylvania, United States
Job Description
Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical (Merck)
Join Merck’s Center for Packaging & Device Analytics (CPDA) in West Point, PA, where interdisciplinary engineering science supports global production and commercialization of medical device and combination products (MDCPs) such as auto‑injectors and pre‑filled syringes.
Responsibilities
Act as MDCP analytical lead for one or more projects, developing and owning analytical strategies that satisfy Design Controls inputs.
Lead cross‑functional working groups to manage timeline and analytical effort, including science, technical oversight and coordination with internal and external testing partners.
Design, validate and implement mechanical test methods and Device Characterization and Design Verification (DV) strategies, including engineering studies, stability studies, and acceptance criteria.
Communicate findings, provide technical coaching and mentor junior staff.
Execute applied physical, material and analytical science to support production and commercialization.
Requirements
Education:
Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent).
Experience:
Minimum 3 years at Ph.D. level in medical device or combination product development, verification, method development and testing.
Skills:
Expertise in mechanical testing, solids imaging and materials characterization (tensile/compression/torsional testing, multibody dynamic FEA, X‑ray CT, microscopy & image analysis, rheology).
Excellent collaboration, leadership, written and verbal communication, and technical coaching.
Experience with Design Controls (21 CFR 820.30) and relevant industry standards is preferred.
Preferred Experience & Skills
Developing innovative Device Characterization and DV strategies with validated acceptance criteria.
Industrial experience in MDCP development and familiarity with Design Controls.
Benefits & Compensation
Salary Range: $139,600.00 – $219,700.00, based on qualifications and business needs.
Eligibility for annual bonus and long‑term incentive.
Comprehensive benefits: medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Hybrid work model: 3 on‑site days per week (Mon‑Thu) with Friday remote (subject to role).
Additional Information
Regular full‑time employment; domestic relocation supported; VISA sponsorship available.
Travel: 10%.
Valid driving license: No required.
Application Deadline: 11/20/2025.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics.
We comply with affirmative action requirements for protected veterans and individuals with disabilities.
More information about your rights can be found at EEOC Know Your Rights, EEOC GINA Supplement, and relevant state acts.
We encourage the application of accommodation requests during the hiring process.
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Responsibilities
Act as MDCP analytical lead for one or more projects, developing and owning analytical strategies that satisfy Design Controls inputs.
Lead cross‑functional working groups to manage timeline and analytical effort, including science, technical oversight and coordination with internal and external testing partners.
Design, validate and implement mechanical test methods and Device Characterization and Design Verification (DV) strategies, including engineering studies, stability studies, and acceptance criteria.
Communicate findings, provide technical coaching and mentor junior staff.
Execute applied physical, material and analytical science to support production and commercialization.
Requirements
Education:
Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent).
Experience:
Minimum 3 years at Ph.D. level in medical device or combination product development, verification, method development and testing.
Skills:
Expertise in mechanical testing, solids imaging and materials characterization (tensile/compression/torsional testing, multibody dynamic FEA, X‑ray CT, microscopy & image analysis, rheology).
Excellent collaboration, leadership, written and verbal communication, and technical coaching.
Experience with Design Controls (21 CFR 820.30) and relevant industry standards is preferred.
Preferred Experience & Skills
Developing innovative Device Characterization and DV strategies with validated acceptance criteria.
Industrial experience in MDCP development and familiarity with Design Controls.
Benefits & Compensation
Salary Range: $139,600.00 – $219,700.00, based on qualifications and business needs.
Eligibility for annual bonus and long‑term incentive.
Comprehensive benefits: medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Hybrid work model: 3 on‑site days per week (Mon‑Thu) with Friday remote (subject to role).
Additional Information
Regular full‑time employment; domestic relocation supported; VISA sponsorship available.
Travel: 10%.
Valid driving license: No required.
Application Deadline: 11/20/2025.
Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics.
We comply with affirmative action requirements for protected veterans and individuals with disabilities.
More information about your rights can be found at EEOC Know Your Rights, EEOC GINA Supplement, and relevant state acts.
We encourage the application of accommodation requests during the hiring process.
#J-18808-Ljbffr