Senior Human Factors Engineer (m/f/d)

Description

Phillips-Medisize, a Koch Company, is building solutions in partnerships with global biopharmaceutical companies to service the expanding need for self-administrated drug delivery devices suitable for especially liquid injectable drugs. To support this growing market with faster timelines to market combined with reduced development risks, several different medical device product platforms are currently in development to provide customers with a head start for launching new drugs.

Do you want to contribute in the design of safe and reliable medical devices, bringing our clients' life-changing solutions into the hands of patients and helping patients to get better treatment?

Then join us and work together with your highly skilled colleagues to bring new products to market in a fast-growing and successful global company!

We are currently hiring a

Senior Human Factors Engineer (m/f/d) - Medical Device Development

fulltime, in Struer or Virum, DK (hybrid working model)

What You Will Do in Your Role

• Contribute during all phases of the product development cycle with particular emphasis on Human Factors Engineering and Usability Assessment.
• Work closely with all disciplines, i.e. regulatory, clinical, marketing, quality, manufacturing, and other functions, regarding potential use errors to improve user safety.
• Represent Human Factors in core team meetings and customer meetings
• Perform analytical use risk analysis to predict and/or assess use error risk potential and identify potential design mitigations.
• Develop and direct formative usability studies during concept development and summative usability studies for human factors validation.
• Write clear testing protocols, set up testing environments, manage recruitment of study participants, schedule research sites, moderate usability sessions (as needed), analyze testing results, identify design improvement opportunities, and author summary reports that adhere to industry standards.
• Direct and/or collaborate on user needs/requirements gathering activities including ethnographic research, use case analysis, and/or task analysis.
• Develop and refine standard operating procedures related to Human Factors Engineering, with close connection to the Product Development Process and Quality Management System.
• Mentor and train Phillips-Medisize staff in basic human factors concepts and methods as appropriate.
• Develop close working relationships with new and existing customers.
• Support the Business Development and Cost Estimation teams in initial customer meetings, scope development and proposal development

The Experience You Will Bring

• BSc. in Design, Engineering, Psychology, or other scientific field and/or Advanced Degree in Human Factors, Cognitive/Experimental Psychology, Ethnography, Anthropometrics
• 5+ years of professional product development experience with a minimum of 3 years’ experience performing the role of Human Factors Engineer
• Intimate understanding of current medical device Human Factors standards and FDA requirements, user research, patient privacy and General Data Protection Regulation
• Medical device development experience
• Experience in human centered design and/or user experience design to drive system level innovation considering use environment, workflow, user needs, technology, and manufacturing.
• Organization and communication skills to plan, communicate and execute project specific Human Factors strategy
• Strong sense of empathy for clinicians and patients

What Will Put You Ahead

• Experience with combination products, such as injection devices or inhalers, or point of care or point of use diagnostic devices.
• Experience with direct FDA engagement
• Statistical data analysis expertise
• Experience with International usability testing

If you are interested in this role, please  apply directly through the link. We are looking forward to your application!

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