Job Description Position Overview: Phillips-Medisize, a Molex Company, is a leading global outsource provider of design and manufacturing services to the medical and specialty commercial markets. The Phillips-Medisize Global Innovation and Development Center is searching for a Senior Human Factors Engineer to join our dedicated product development team.
The Senior Human Factors Engineer will make meaningful contributions throughout our Design Development Process, with a special emphasis on medical device product development. The candidate should be able to relate human factors activities to the medical device Design Controls process. The candidate must possess a diverse skill set and should enjoy working in a collaborative multi-disciplinary environment.
Contribute during all phases of the product development cycle with particular emphasis on Human Factors Engineering and Usability Assessment
Perform analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations
Ability to write clear testing protocols, set up testing environments, manage recruitment of study participants, schedule research sites, moderate usability sessions, analyze testing results, identify design improvement opportunities, and author summary reports that adhere to industry standards
Assist with conformance to Design Control and FDA guidance to ensure product quality through human factors focused technical reviews
Translate research results into objective and actionable design direction
Act as an interface between the product development team and other related disciplines (ie. regulatory, clinical, marketing, quality, manufacturing, and other functions) regarding potential use error issues as they may relate to user/patient safety
Mentor and train Phillips-Medisize staff in basic human factors concepts and methods as appropriate
Develop close working relationships with new and existing customers
Perform other work-related duties as assigned
Job Number 9108BR
Career Field Engineering
Position Qualifications Required Qualifications:
Bachelor Degree in Design, Engineering, Psychology, or other scientific field and/or Advanced Degree in Human Factors, Cognitive/Experimental Psychology, or other related field (advanced degree is strongly preferred)
Medical device development experience (especially drug delivery), familiarity with medical environments/terminology, and strong sense of empathy for clinicians and patients is highly desired
Skills and Abilities:
Intimate understanding of current medical device Human Factors standards and FDA requirements (ie. ISO/IEC-62366, FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices)
Experience with direct FDA engagement is strongly desired (proven history of successful regulatory collaboration)
Demonstrated proficiency with qualitative and quantitative data analysis methodologies (statistical data analysis expertise is strongly desired)
Experience with International usability testing (ie. Europe, Asia, etc.) is strongly desired
Strong computer skills and competency with applicable video editing and statistical analysis software
Ability to travel domestically and internationally as needed (occasional)
This position does not qualify for VISA sponsorship In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.
About Phillips-Medisize, LLC... Phillips-Medisize, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.