Human Factors Engineer

Actalent; Burgdorf; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Actalent seeks an experienced Human Factors Engineer & Service Lead to drive HF excellence across international pharma and combination product programs.

You will build HF consulting services, guide partners on regulatory strategies, and lead large usability studies with a mix of users worldwide.

Qualifikationen

• Bachelor's or Master's in Human Factors, Ergonomics, or related field.
• Minimum of 7 years in Human Factors consulting in medical devices or healthcare.
• Experience developing and delivering large-scale usability studies and HF programs.
• Strong project management with ability to run multiple complex projects.

Aufgaben

• Build, develop, and scale the Human Factors service offering, partnering with Business Development.
• Advise pharmaceutical partners on HF requirements for combination products and regulatory pathways.
• Lead international HF studies: planning, budgeting, timelines, execution, and reporting.
• Design and document formative, summative, and comparative usability studies with diverse participants.
• Manage external consultants, testing facilities, and vendors as needed.
• Lead HF activities related to IFU, UI, and usability programs.
• Prepare and maintain HF documentation for global regulatory submissions.
• Collaborate to translate HF insights into evidence-generation strategies and publications.
• Monitor global HF regulations and industry trends to advance best practices.

Kenntnisse

Human Factors

Project management

Business development

Regulatory knowledge

Stakeholder management

Communication skills

Travel readiness

Ausbildung

Bachelor's or Master's in HF/Ergonomics

Jobbeschreibung

Our client is an innovative leader in the medical technology sector, developing solutions that improve the lives of people living with chronic conditions worldwide. To strengthen its growing service offering, our client is seeking an experienced Human Factors Engineer & Service Lead to drive Human Factors (HF) excellence across international pharmaceutical and combination product programs.

In this strategic and customer-facing role, you will establish and expand Human Factors consulting services, advise global pharmaceutical partners on HF strategies, and lead complex usability engineering activities supporting successful product development and regulatory approvals. This is a unique opportunity to combine technical expertise, business development, and project leadership while contributing to user-centered healthcare solutions.

Responsibilities

• Build, develop, and scale the Human Factors service offering, working closely with Business Development to identify and secure new service opportunities.
• Act as a trusted advisor to pharmaceutical partners, providing strategic guidance on Human Factors requirements for combination products and optimizing regulatory pathways.
• Lead and coordinate international Human Factors studies, including project planning, budget management, timelines, execution, monitoring, and reporting.
• Design, oversee, and document formative, summative, and comparative usability studies involving diverse user populations and large participant groups.
• Manage external consultants, testing facilities, research partners, and vendors as needed.
• Lead or support Human Factors activities related to Instructions for Use (IFU), user interfaces, and overall usability engineering programs.
• Prepare, review, and maintain usability engineering documentation required for global regulatory submissions, including Human Factors reports, study reports, and threshold analyses.
• Collaborate with cross-functional teams to translate Human Factors insights into evidence-generation strategies, scientific publications, and product differentiation initiatives.
• Monitor global Human Factors regulations and industry trends, contributing to the continuous development of best practices and organizational expertise.

Must-Haves

• Bachelor's or Master's degree in Human Factors, Ergonomics, Usability Engineering, Psychology, Product Design, or a related discipline.
• Minimum of 7 years of experience in Human Factors consulting, ideally within the medical device, drug-device combination product, or related healthcare industry.
• Proven experience developing and delivering Human Factors programs, including planning, conducting, and documenting large-scale usability studies.
• Strong project management skills with the ability to manage multiple complex projects simultaneously.
• Entrepreneurial mindset with strong business acumen and a demonstrated ability to develop and grow customer-focused service offerings.
• Solid understanding of global regulatory requirements and submission processes, including experience with regulatory agencies such as the FDA, EU MDR, NMPA, and Health Canada.
• Excellent stakeholder management, communication, and presentation skills with the ability to engage effectively in international and cross-cultural environments.
• Professional English proficiency (C1 level or higher); German is considered an advantage.
• Willingness and ability to travel internationally up to approximately 20% of the time, including travel to the United States.