Job Title : Human Factors Expert
Location : Thuiswerken in Oss
Company : Organon
Salary :
Open Date : 2023-05-11
Close Date : 2023-09-11

Organon are recruiting for the position of Human Factors Expert to join our world class technical operation team that support and manage Organon’s Medical Devices and Combination Products.

In this role, you will operate as a leading member of the Human Factors team with the expectation of autonomously managing the Human Factors process for the development of next generation medical devices and combination products, including those newly acquired, legacy products and lifecycle changes to existing product portfolios.

In parallel to which you will also drive and champion continuous improvement of existing processes, ways of working and ensuring Human Factors activities are completed in an aligned manner with Design Control and Risk Management processes and requirements.

Responsibilities:

• Leading the delivery of Human Factors activities for assigned projects within the product portfolio.
• Generation of objective evidence which confirms to defined Human Factors processes and that mandated by state-of-the-art standards and Industry Guidance.
• Collaborate with cross functional development teams to ensure Human Factors requirements are captured in the product’s Design Control and Risk Management records.
• Support Human Factors activities through all stages of the product life cycle, including development and post market surveillance.
• Collaborate with external vendors to develop and execute Human Factors studies in support of medical device and combination product submissions.
• Lead construction of responses to Competent Authorities concerning Human Factors evidence for Organon’s medical devices and combination products.
• Communicate effectively with both internal and external audiences to influence change and build consensus.

Requirements:

• Significant, relevant industry experience in medical devices, pharmaceuticals or in biotech organizations.
• Technical BS degree or higher (MS or PhD) in Human Factors Engineering or related discipline.
• Applied and demonstrable experience of leading Human Factors projects in support of regulatory submissions.
• Applied and demonstrable experience of Human Factors, Medical Device and Combination Product regulations.
• Applied and demonstrable experience of generating Human Factors documentation including, Intended use specifications, User Interface specifications, URRA, formative and summative study protocols and reports, and Human Factors Summary Reports.
• Applied and demonstrable experience of use error analysis in the context of residual risk and resultant harm.
• Applied knowledge of common usability techniques including contextual, cognitive and heuristics analysis.
• Experience of project team management.
• Experience managing a project portfolio with multiple projects running at any one time.
• Enhanced knowledge of Design control, Risk Management, Medical Devices and combination products.
• Excellent problem-solving skills, including lateral and systematic thinking.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at [email protected].

Search Firm Representatives Please Read Carefully
Organon LLC, 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.

Salary Range

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

25%

Flexible Work Arrangements:

Remote Work

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R518722

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