Job Description

Job Description

As a Senior Scientist in Device Design and Process Development group, you will be part of our R&D team that develops drug delivery systems and combination products.

Key Responsibilities:

• Collaborate with systems engineering team to develop robust set of design input requirements based on user needs and target product profile.

• Gain deep understanding of drug delivery systems from a first principles perspective becoming a subject matter expert on the form, fit and function of the device constituent part of the combination product.

• Apply DFM/DFA principles to interrogate sourced device components or design bespoke device components.

• Develop test plans to understand design space and to ensure device technology is adequately suited for the combination product.

• Conduct or analyze tolerance stack ups utilizing worst-case and statistical methods such as RSS or Monte-Carlo simulation.

• Identify critical to function/safety and critical to process dimensions and ensure adequate controls exist to maintain device performance within acceptable range.

• Conduct testing using tensile tester and or other laboratory equipment and analyze data to inform design development activities.

• Interface with key stakeholders in cross-functional development teams and provide technical insight and leadership on the device design aspects of the development program.

• Travel to OEMs/Suppliers to review product design, functional data, manufacturing processes and conduct due diligence on robustness of their product and process.

• Author design/ process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.

• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.

• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.

• Understand Process validation activities like IQ, OQ, PPQ etc. Review and approve Process validation documentation.

Education qualifications:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related fields with 5 years of design and mechanical testing experience Or

• Master's Degree in Mechanical Engineering, Biomedical Engineering, or related fields with 3 years of design and mechanical testing experience.

Required:

• Proficient in creating solid models, assemblies etc. using computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD, ArtiosCAD etc.

• Proficient in creating and reviewing detailed engineering drawings, applying basic GD&T principles for dimensioning and tolerancing.

• Strong problem-solving, analytical, technical writing and presentation skills with high level of proficiency in utilizing MS Office Suite

• Ability to analyze data using statistical software such as Minitab.

• Hands on experience in developing test methods and fixtures for tensile tester, conducting method feasibility, Gauge R&R evaluation, and method validation.

• Excellent collaborative and communication skills, with a proven ability to work effectively with cross-functional teams and external partners to achieve strategic business goals.

• Ability to perform modeling and structural design of secondary packaging with output for prototyping in multiple materials including paper.

• Knowledge of standards (ASTM/ISTA) for evaluation and qualification of packaging systems.

Preferred:

• Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.) and industry standards related to medical device manufacturing is a plus.

• Experience in the design and development of drug delivery systems such as prefilled syringes and autoinjectors.

• Experience in machining, prototyping and 3D printing.

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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, 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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R335653