Senior Scientist, Medical And Combination Product Design Verification

Job Description

Our Company's Device Development (DD) Team is seeking a highly motivated and passionate Senior Engineer or Senior Scientist for a hands-on, Subject Matter Expert (SME) role in medical and Combination Product Design Verification & characterization testing. In this role, the individual will lead the Design Verification strategy (preclinical to commercialization) for development programs spanning an array of Combination Products, such as pre-filled syringes, auto-injector pens, on-body infusers/injectors, inhalers and more. This position is directly responsible for method functionality and compatibility testing of new and/or novel medical devices, primary containers, and Combination Products during concept, early development and commercialization. This position will collaborate with other subject-matter experts in the DD team (design controls & risk management, manufacturing, molding, and human factors) and other key partner groups to identify and develop device functionality test protocols/methods, qualify, validate and tech transfer to external testing facility when needed.

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 project/program needs, engage and mentor team members, formulate strategy, build support for and execute; proactively identify and mitigate risks.

• Strong working knowledge of Break-Loose & Glide (Extrusion) Force (BLGF), Leak-Burst, mechanical strength testing, and Container-Closure Integrity (CCI) testing

• 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

Expertise in testing, characterization, and troubleshooting of:

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

• Assemblies (including electro-mechanical) – system tear down analysis, gear ratio optimization, weakest link component identification and optimization, etc.

• Material characterization and failure mode analysis

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

• Conduct 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:

• 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 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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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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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:

On-Site

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R276592