Associate Principal Scientist, Device Product and Process Development

Job Description

Our Company's Device Product and Process Development (DPPD) 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 pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. They 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 are often assemblages of glass pre-filled syringes, injection molded plastic components driving delivery of a drug, typically though mechanical or electro-mechanical means. Examples include, but not limited to, injector pens and inhalers.  

Education Requirement (minimum):

• Ph.D. in Mechanical Engineering or equivalent field is required.

Required Experience and Skills:

• A minimum of a Ph.D. plus 4 years of device design and engineering evaluation experience.
• Fluency in structural finite element analysis (FEA).
• Solid testing and troubleshooting skills able to work independently in a laboratory setting
• Experience 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.
• 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 mechanical engineering 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.

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

PSCS

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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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. 

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