Senior Scientist / Engineer, Device & Combination Product Design Verification (Hybrid)

Job Description

Are you passionate and motivated about developing tailored testing strategy for unique Combination Products? Join our Company's Device Development team as Senior Engineer or Senior Scientist and be at the forefront of innovation, leading the charge in designing and implementing specialized testing methodologies for each Combination Product we develop. We are seeking individuals with expertise in Design Verification & characterization testing for the development and commercialization of Combination Products, including prefilled syringes, auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and Combination Product Design Verification, the candidate will lead the strategy and execution of Design Verification activities from concept to commercialization. As part of our dynamic and diverse team of experts, the candidate will spearhead the technical and scientific feasibility evaluation of the Combination Product and its components. The candidate will be responsible for establishing design input requirements and essential performance requirements (EPRs) and developing the respective Design Verification testing strategy and execution plan. The candidate's expertise in testing methodologies development and validation strategies will be crucial in ensuring the reliability and accuracy of our results. Furthermore, the candidate will play a pivotal role in driving seamless technology transfers and conducting investigations as needed for our cutting-edge Combination Products. Join us and be part of a fulfilling and exciting journey in revolutionizing healthcare through the development of life-changing Combination Products where your expertise and drive will be valued and celebrated.

Education Requirement (minimum):

• B.S. in Mechanical Engineering or equivalent field is required

Preferred Education:

• M.S or Ph.D. in Mechanical Engineering or equivalent field

Specific requirements include:

• B.S. in Mechanical Engineering (or an equivalent field) + 6 years relevant industry experience; M.S. in Mechanical Engineering (or an equivalent field) + 3 years of experience in the medical device and/or Combination Product industry; or a Ph.D. in Mechanical Engineering (or an equivalent field).

• Ability to assess program needs, formulate, develop, and execute strategy, proactively identify and mitigate risks, engage, collaborate, mentor, and inspire team members.

• Strong working knowledge of ISO standards such as 11608, 11040 performance tests and studies including break loose and extrusion force (BLEF), breakage and burst resistance, dose accuracy, and container closure integrity to mention a few.

• New mechanical test method development, qualification, and validation.

• Working knowledge of analytical test method tech transfer processes and procedures (internal and external).

• Working knowledge of design controls and risk management processes for medical devices and Combination Products, including establishment of design inputs, design outputs, Design Verification, and risk management integration.

Expertise in testing, characterization, and troubleshooting of:

• Combination product drug delivery device components - plastic, metal, glass, elastomeric materials, etc. - fracture, stress-strain response, friction, hardness, surface roughness, surface energy quantification.

• Combination product sub-assemblies (including electro-mechanical) - system tear down analysis, gear ratio optimization, weakest link component identification and optimization, etc.

• Material characterization and failure mode analysis and integration with Combination Product risk management.

• Stress-strain testing of different materials under different environmental conditions, i.e., temperature, humidity.

• Conduct aging studies (e.g., accelerated and real time) and root cause investigations of drug delivery systems, e.g., inhalers, auto injectors, pen injectors, on-body infusers/injectors, etc...

• Eagerness to identify lab capability gaps, drive procurement of new equipment, and quickly upskill (also train others) on operation.

• Experience with analytical or numerical simulation.

• Excellent collaboration and ideation skills, including facilitating brainstorming sessions, developing proof of concepts, and generating feasibility data.

• Skilled in laboratory good documentation practices and electronic documentation systems.

• Excellent communication skills, written and oral.

• Promote and leverage diversity to achieve best outcomes.

Preferred experiences include:

• Experience in the development and commercialization of drug delivery Combination Products from Design Verification standpoint.

• Strong familiarity with regulatory landscape associated with drug delivery Combination Product Design Verification requirements.

• Strong familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], high speed imaging)

• Experience in 3D CAD (Solidworks) and rapid manufacturing techniques (machining, 3D printing) for fixture development and device redesign efforts.

Fluency with industry-related guidance & standards:

• 21 CFR Part 4

• 21 CFR 820

• 21 CFR 211

• USP <1>

• USP <697>

• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics

• ISO 13485

• ISO 14971

• ISO 11608

• ISO 11040

• ISO 10993

• ISO 23908

ISTA 3A/B

NOTICEFORINTERNALAPPLICANTS

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 separationpackage, 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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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, 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".

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/28/2024

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:05/28/2024

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:R294609

PDN-9c0bbdb6-fe75-40df-a100-1e959d7aebc3