Associate Director, Engineering | Human Factors

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our Company's Manufacturing Division Packaging and Combination Product Commercialization is seeking a Human Factors Engineer to join the commercialization team. The focus of the role is to provide Human Factor and Usability Engineering expertise in support of our company's pipeline and inline portfolio. Using the technical frameworks of human factors, medical device risk management, and usability engineering, as well as the application of the state of the art is in this discipline, the human factors engineer will support setting program strategy based on user and product characteristics.

The Human Factors Engineer is responsible for detailed planning of activities as well as the tactical execution, data management and summary authoring in support of new product registration. Leveraging technical knowledge and intra-personal skills, the human factors engineer will work to ensure that development teams appropriately identify and maintain user focused design elements and appropriately include in requirements documentation. As a subject matter expert, this role is expected to consult with other functions and be able to build coalitions across functions in support of the end user and safe and effective use of processes. The candidate will possess strong project management skills as to support file and launch on-time goals, as well as ensuring that use-related risks are appropriately identified and mitigated throughout the product lifecycle. The human factors engineer will prepare and be accountable to regulatory submission documents.

Education Requirements

• Bachelor or Master of Science in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or equivalent

Experience and Skills

Required

• Strong intra-personal, planning, communication, and assessment skills as well as demonstrated ability to integrate user-focused design into development projects

• Effective GMP and Pharmaceutical/Medical Device disciplines

• Minimum 7 (seven) years in the Human Factors discipline

• Proficiency with Microsoft Office and Microsoft Project, including cloud computing, remote work, and productivity software

• Detailed knowledge and practical experience with a variety of human factors approaches

• Medical Device Risk Management per ISO 14971

• Knowledge and practical experience with FDA Human Factors Guidance as well as ISO-IEC 62366

• Knowledge and Practice in medication error reduction approaches

• Familiarity with Pharmaceutical or Medical Device development processes and change control

• Ability to integrate into and influence multiple teams concurrently

• Laboratory testing, verification testing, or empirical data review and analysis

• Awareness of evolving regulatory expectations in this field

• Ability to maintain and develop an external network in support of technical and strategic objectives, as well as mentor and guide newer contributors in this discipline

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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.

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.

For more information about personal rights under Equal Employment Opportunity, 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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R122604