Human Factors Specialist - Hamburg, Deutschland - Olympus Europa SE & Co. KG

Olympus Europa SE & Co. KG

Geprüftes Unternehmen

Hamburg, Deutschland

vor 4 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Responsibilities:

Conduct use research and stay up to date with the latest medical device technology and industry trends.
Support the design and development teams for medical devices, software, equipment, and instruments.
Collaborate with crossfunctional teams including product managers, engineers, risk managers, regulatory affairs personnel and clinicians to ensure products are safe, effective, and compliant with relevant regulations.
Conduct and manage the execution of formative and summative evaluations to ensure products meet design specifications and are safe for use in medical settings.
Participate in design reviews and provide input on design improvements and changes.
Collaborate with external designers, usability test agencies and recruiters.
Create human factors engineering documentation such as use specifications, use related risk assessments, test plans, and reports.
Follow design control processes and ensure compliance with relevant regulations, such as FDA and ISO requirements.

Your qualification

Degree in Human Factors / Usability Engineering, Engineering, Biomedical Engineering, or within a related field.
Several years of experience in medical device design, preferably in a company within a regulated industry.
Deep knowledge of related FDA and ISO regulations for medical devices and experience with design control processes.
Fluent language skills in German and English
Excellent communication, problemsolving, and teamwork skills.
Ability to work in a fastpaced, dynamic environment and manage multiple projects simultaneously.
Strong attention to detail and commitment to quality.

Your benefits