Senior Human Factors Engineer
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.
- Bachelor Degree in Design, Engineering, Psychology, or other scientific field and/or Advanced Degree in Human Factors, Cognitive/Experimental Psychology, or other related field
- At least 3 years Product Development experience
- Experience developing Medical devices
- Experience with medical terminology
- Experience with Human Factors standards and FDA requirements (ie. ISO/IEC-62366)
- Demonstrated proficiency with qualitative and quantitative data analysis
- Experience understanding and following applicable safety, quality, and environmental programs, policies, and procedures
What will put you ahead?
- Advanced degree is strongly preferred
- Strong sense of empathy for clinicians and patients
- Experience with direct FDA engagement
- Experience with International usability testing (ie. Europe, Asia, etc.)
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.
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