Associate Scientist / Engineer - Device & Combination Product Design Verification

Job Description

Our company's Device Development is seeking a highly motivated, talented engineer R1 with a strong background in Combination Product Development, Design Verification, and perform preclinical programs mechanical testing to join our department at our Research Laboratories in Rahway, NJ. The successful candidate will be part of a multi-disciplined team driving programs for oncology, neuroscience, cardiovascular, and infectious disease areas. Device development works through the preclinical development of Medical Devices and Combination Products for a wide range of Drug Product dose presentations, including parenteral, syringes, auto-injector pens, inhalation and nasal drug products. The ideal candidate will be adept in engineering assignments involving Develop innovative Design Verification mechanical tests, computer aided design (CAD) and rapid prototyping (e.g. 3D Printing) test fixture for Combination Products and Medical Devices testing, through Concept and Design phases, Implementation of lead prototypes, Verification of Design through finite element analysis (FEA) and Mechanical Testing through to Transfer and Validation of Device Design. You will be expected to work independently and to proactively collaborate with cross functional teams, leading pipeline products and standalone medical device designs.

Key Responsibilities and Primary Activities:

• Mechanical test method development and validation

• Lead Design Verification development programs' testing on interdisciplinary teams to advance the development of Combination Products

• Help to generate and develop design input requirements (DIRs)

• May lead and implement departmental and inter-departmental initiatives (e.g. new technology, improved collaborations between different departments, development and implementation of new business processes, etc.).

• Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.

• Work with cross-functional teams to assist in the development of 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.

• Design and rapid prototype medical device and Combination Products using state of the art tools including CAD, FEA, and 3D Printing.

• Work with second- and third-party suppliers and vendors.

• Apply scientific and engineering expertise to solve problems creatively and independently.

• Document results in electronic notebooks and formal reports/memos as needed.

• Communicate findings and interpret results to key stakeholders via written reports and presentations.

Requirement:

• B.S degree in Mechanical Engineering or related scientific discipline (or an expected graduation date by May 2024)

Preferred:

• Hands on experience with Combination Product Design Verification & functional test method development

• Familiarity with pharmaceutical development, Combination Product Design controls, and device development

• Familiarity with Combination Product mechanical testing

• Familiarity with Industry Related Knowledge

• 21 CFR Part 4

• 21 CFR 820

• 21 CFR 211

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

• ISO 13485

• ISO 14971

• ISO 11608

• ISO 11040

• ISO 10993

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:

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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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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:

$68,400.00 - $107,700.00

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:

No relocation

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:R278453