Sr. Human Factors Engineer - Medical Devices
Phillips-Medisize is a leading global outsource provider of design and manufacturing services to the medical (medical device, diagnostics, and drug delivery products) and specialty commercial markets. Our Human-Centered Design team is seeking an experienced Senior Human Factors Engineer to join our cross functional group. We believe that good things happen at the intersection of art and science. Creative expression plus engineering rigor produces design innovation. The ideal candidate will share our passion for serving patients, caregivers, and healthcare professionals through our work.
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 familiar with human factors standards and guidance documents, will be well versed in risk management and usability assessment techniques, should be able to demonstrate proficiency with human performance evaluation, and 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.
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.
- Direct and/or collaborate on user needs/requirements gathering activities including ethnographic research, use case analysis, and/or task analysis.
- Perform analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations.
- Develop and direct formative usability studies during concept development and summative usability studies for human factors validation.
- 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.
- Develop and refine standard operating procedures related to Human Factors Engineering, with close connection to the Product Development Process and Quality Management System.
- Develop and deliver human factors related presentations to internal and external stakeholders.
- 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.
The experience you will bring.
- Medical device development experience (especially drug delivery), familiarity with medical environments/terminology
- 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)
- Demonstrated proficiency with qualitative and quantitative data analysis methodologies
- Excellent writing, organizational, presentation, and interpersonal communication skills are essential
- Self-directed and able to work effectively within a team environment
- Strong computer skills and competency with applicable video editing and statistical analysis software
- Ability to work at a fast pace and navigate through ambiguity while keeping the end goal in focus
- Ability to understand and follow applicable safety, quality, and environmental programs, policies, and procedures
- Ability to travel domestically and internationally as needed
- 5+ years of professional product development experience
- Must be able to represent the facility in a competent and professional manner with all people
- Working knowledge of engineering and manufacturing economics
- Sound general understanding of business finance
- Excellent skills in verbal communication, written documentation, and proposal development
- Bachelor Degree in Design, Engineering, Psychology, or other scientific field and/or Advanced Degree in Human Factors, Cognitive/Experimental Psychology, or other related field
What will put you ahead?
- Advanced degree is strongly preferred
- Strong sense of empathy for clinicians and patients is highly desired
- Experience with direct FDA engagement is strongly desired; proven history of successful regulatory collaboration
- Statistical data analysis expertise is strongly desired
- Experience with International usability testing (ie. Europe, Asia, etc.) is strongly desired
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.
Salary and benefits commensurate with experience.
Equal Opportunity Employer.
Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.
This employer uses E-Verify. Please visit the following website for additional information: www.kochcareers.com/doc/Everify.pdf