Job Abstract

Job Description

Our company's Device Development (DD) Team is seeking a hands-on analytical characterization and design focused engineer. 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. 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 injection molded plastic components driving delivery of a drug, typically though mechanical (i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) means. Examples include, but not limited to, injector pens and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches. Additionally, this position will leverage design and prototyping skills to ideate, breadboard, and reduce to proactive novel drug delivery device concepts.  

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 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 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 expertise in fracture mechanics including both experimental and modeling, particularly related to glass breakage

• Experience with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, tensile/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 finite element analysis (FEA) and computational fluid dynamics (CFD).

• 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:

• Develop innovative 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.

• 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

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

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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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