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Senior Human Factors Engineer

Description

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.

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 In Your Role

  • Contribute during all phases 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 (ie. 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.
  • 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.
  • 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

Requirements:

  • Bachelor's degree in Design, Engineering, Psychology, or other scientific field 
  • A minimum of 5 years of professional product 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
  • Strong sense of empathy for clinicians and patients 

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.
  • Experience with direct FDA engagement
  • 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.


Phillips-Medisize is a global contract design and manufacturing organization that specializes in serving the health care industry. Our founder believed PEOPLE are the difference. We believe this is still true today and have maintained this core value, enabling Phillips-Medisize to attract, develop and retain talent throughout our global organization. Emphasis on, and investment in our people has created a culture of innovation and industry-leading technology development.

Our Global Innovation and Development network, located in the United States, Europe, India and China is comprised of over 600+ engineers with disciplines that span the product develop, manufacturing development and clinical manufacturing lifecycles. We leverage the power of collaboration throughout our well-established design and development process to serve our customers and end users.


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.


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.


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: www.kochcareers.com/doc/Everify.pdf

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