Device Development Scientist – Human Factors

Job Description

The scientist in this position will be responsible for performing and managing human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in our Company's portfolio and pipeline including acquisition products. The scientist in this position will apply knowledge of human performance (perceptual, cognitive, and motor skills) and Human Factors techniques to a wide range of systems’ issues, across the product lifecycle: including customer needs identification, user profiles, task analysis, use risk analysis, user interface design, usability testing, hazard analysis, and post-launch outcomes analysis.

Principal Responsibilities:

• Perform and manage human factors activities throughout the whole product design and development cycle within the constraints of a regulated environment, including creating human factors plan, working with other disciplines to identify customer needs, intended use and potential hazard/harm, providing product and packaging design inputs/requirements, performing task and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need.

• Collaborate with cross-functional colleagues to create innovative and intuitive-to-use products and ensure regulatory compliance. The cross functional team includes marketing, product planning/project managing, development, clinical, regulatory, purchasing, manufacturing, and labeling.

• In collaboration with cross-functional colleagues, ensure the management and maintenance of records and databases that support regulatory compliance

• Collaborate cross- functionally to support and maintain the internal HFE processes to ensure consistency, efficiency and compliance

• Support other quality and GMP compliance activities relating to combination products and medical devices

• Perform scientific literature reviews and database research on various topics independently and synthesize relevant information in support of the human factors research Perform other job related duties or special projects as required.

Qualifications:

Minimum Requirements:

• B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology plus three years of related experience or M.A/M.S. in one of the above disciplines

• Proven analytic skills in the product design, development and evaluation

• Proven project management skills

• Self-motivated and work independently

• Proven ability to work with multidisciplinary teams.

• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership

• Excellent communication, presentation, negotiation, project management and organizational skills.

• Willing to travel.

• Able to quickly pick up advanced domain knowledge.

• Able to multi-task continuously.

Preferred Requirements:

• M.A/M.S. in one of the above disciplines

• Working knowledge of medical device or pharmaceutical industry.

• Knowledge with U.S. and global Medical Device and healthcare regulations, including FDAs combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.

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., Rahway, 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

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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.

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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.

Under New York City, 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:

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.

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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:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R226570