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Job Information

Merck Associate Principal Scientist, Device Mechanical Design and Analytics in Rahway, New Jersey

Job Description

Our Company's Device Development (DD) Team designs, develops and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DD Team manages the development of the device constituent of our Company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation and injection.

We are seeking an Associate Principal Scientist/Engineer capable of applying the fundamental principles of mechanical design and engineering to ensure achievement of robust device performance, manufacturing processes and high-quality combination products. This position will interact extensively with all subject-matter experts within the DD team as well as with members of numerous internal cross-functional product development teams from concept through product launch. The position’s focus will be the design, optimization, and development of drug delivery devices using engineering tools during early development (pre-Design Verification). In addition, the position will lead, when necessary, post-Design Verification (DV) failure mode investigations to identify and mitigate technical design issues.

The individual will work to ensure combination products are developed in accordance with applicable regulatory, quality, company, and customer requirements.

Primary Responsibilities:

  • Lead the pre-DV drug delivery platform evaluations and design optimizations for select development programs:

  • Actively engage and support the Device Development Engineering Core team to ensure the combination product and engineering execution against the established requirements.

  • Lead the pre-DV drug delivery platform characterization, this includes, but is not limited to, kinematic analysis, material evaluations, engineering testing, first principal analytical calculations, and identification of potential failure modes and risks.

  • Lead the pre-DV drug delivery platform design, optimization, and development, this includes, but is not limited to, designing for function and manufacture, 3D modeling, tolerance analysis, etc.

  • Serve as key point-of-contact with potential external device designers, developers and suppliers for select device technology platforms.

  • Provide strong technical support to program managers after DV and lead post-DV failure mode investigations through testing and analytical methods.

  • Maintain a high level of engagement in all device development activities (e.g., engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis).

  • Maintain a high level of engagement in the program-specific design controls process and design history file development.

Education Minimum Requirements:

  • A Master’s degree in Engineering or Science.

Required Experience and Skills:

  • A minimum of 7 years related product development experience; drug delivery device experience preferred.

  • Proficient in mechanical design of mechanical and electromechanical devices and strong familiarity with CAD, able to quickly turn concepts into drawings and prototypes.

  • Strong background in mechanics of materials, especially with elastomers & plastics. Good understanding of material property characterization through analytical tools.

  • Good understanding of design for manufacture; includes injection molding and multiple component assembly processes.

  • Proven track record of applying critical thinking and technical problem-solving skills in product and process design and development and proficient in Failure Mode Analysis.

  • Ability to manage multiple projects and effectively prioritize.

  • Excellent verbal and written communication skills.

  • Strong interpersonal, networking and project planning and management skills.

  • Driven, self-motivated and passionate in delivering healthcare solutions for patients .

Preferred Experience and Skills:

  • Experience in numerical simulation tools, e.g., FEA, CFD, and is capable of executing such analysis to understand the critical parameters to optimize product performances.

  • Experience and deep working knowledge of device and/or biologic/drug product and process development including regulatory submission and approval processes.

  • Knowledge of current good manufacturing practices (GMPs) for combination products.

  • Experience with development of design history file (DHF) deliverables for medical devices. 

  • Knowledge of applicable medical device regulations (21CFR820, MDD/MDR, ISO 13485).

  • Medical Device Risk Management experience (ISO 14971).

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R84366

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