Your Job
Phillips-Medisize is seeking a Senior Human Factors Engineer to expand our ability to serve customers throughout the product development lifecycle. The position is located in our newly renovated Global Innovation and Development center in Hudson Wisconsin, which in 2021 completed an $8 million dollar renovation that provides our employees improved workspace, labs and collaboration spaces as well as increased capacity to design, prototype, manufacture, test and accelerate launch for our customers.
This role is eligible for hybrid working with the ability of working a majority remote and traveling to Phillips-Medisize offices/customers.
Our Team
The Senior Human Factors Engineer will work collaboratively with other team members of our product development, manufacturing development, quality, and program management groups to help us understand user needs and use risks and refine the design to reduce the potential for patient harm. Human Factors Engineering is an integrated part of our design and development process and team culture, contributing to design assessment and testing, as well as ideating with the team on solutions to improve the user experience and reduce use risk.
What You Will Do
- Contribute during all stages of the product development cycle with particular emphasis on Human Factors Engineering and Usability Assessment.
- Act as an interface between the product development team and other related disciplines (i.e., regulatory, clinical, marketing, quality, manufacturing, and other functions) regarding potential use error issues as they may relate to user/patient safety.
- Perform analytical use risk analysis to predict and/or assess use error risk potential and identify potential design mitigations.
- Determine and advocate for appropriate human factors activities based on customer needs and expertise to progress the development of the product.
- Provide human factors expertise including execution and support of formative usability studies during concept development and summative usability studies for human factors validation.
- Develop clear study designs and testing protocols, set up testing environments, moderate usability sessions, analyze testing results, identify design improvement opportunities, and create 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 and other applicable regulations in the execution of all activities.
- Mentor and train Phillips-Medisize staff in basic human factors concepts and methods as appropriate.
- Develop close working relationships with new and existing customers.
- Lead and contribute to process improvement initiatives.
- Provide oversight and support for human factors activities executed by third party partners/consultants.
- Support the Business Development and Cost Estimation teams in initial customer meetings, scope development and proposal development
Who You Are (Basic Qualifications)
- Bachelor’s Degree in Design, Engineering, Biomedical, Psychology, or other scientific field
- A minimum of 5 years of professional development experience
- A minimum of 3 years experience performing the role of Human Factors Engineer
- Medical device development experience
- Understanding of current medical device Human Factors standards and FDA requirements
- Technical writing experience with GDP, GMP documentation practices
- Experience facilitating communication with a variety of stakeholders internally and externally
What Will Put You Ahead
- Advanced degree in Human Factors, Cognitive/Experimental Psychology, or other related field
- Experience with combination products, such as injection devices or inhalers, or point of care or point of use diagnostic devices.
- Direct experience with notified bodies or regulatory agencies
- Statistical data analysis expertise
- Experience with International usability testing
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.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Hiring Philosophy
All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.
Who We Are
As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Our Benefits
Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength – focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes – medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.
Equal Opportunities
Equal Opportunity Employer, including disability and protected veteran status. 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: http://www.kochcareers.com/doc/Everify.pdf