Human Factors

Manager of Human Factors and Usability Engineering

Balionis Group, Inc. is well known for providing engineers and technology people to a variety of high technology firms.  We provide direct placement as well as contract engineers.

We are currently looking for a Manager of Human Factors and Usability Engineering for a permanent position within our client base.  This position is permanent and is based in Pittsburgh, PA.

This position offers a huge opportunity for the right person.  Our client is in the Medical Device Industry.

Essential Duties and Responsibilities:

  • Define and champion design thinking and usability research best practices within an agile organization by working closely with a cross-functional development team to ensure that user needs, usability requirements, and use errors are identified and addressed through all phases of the system lifecycle.
  • Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs
  • Develop collaborative working relationships with other functions within the product development organization such as design quality, regulatory, engineering design, clinical development engineering, and product marketing.
  • Ensure the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies.
  • Apply FDA human factors processes towards the development of medical devices and follow the guidelines of the FDA and other regulatory bodies (e.g. IEC 62366, AAMI HE75).
  • Organize and direct the work of human factors engineering staff and outside consultants to effectively and efficiently support product development efforts within the company.
  • Lead the team’s collaborative work with the regulatory group to develop strategies for new product submissions, development process improvements, and respond to questions from regulatory agencies.
  • Recruit, develop, and retain high performing human factors and usability engineering staff.
  • Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.

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Principal Human Factors Engineer

Balionis Group, Inc. is well known for providing engineers and technology people to a variety of high technology firms.  We provide direct placement as well as contract engineers.  We are currently looking for a Principal Human Factors Engineer for a permanent position within our client base.  This position is permanent and is based in Pittsburgh, PA.

This position offers a huge opportunity for the right person.  Our client is a medical device firm, with a successful product on the market now.  Newer versions of the product are being designed, along with additional complimentary clinical products being considered.

Our client is growing their R&D team, including their Human Factors Engineering group.

 Essential Duties and Responsibilities:

  • Drive patient-focused product innovation by leading the development of human factors engineering processes within the organization, including the management of standard operating procedures.
  • Works closely with a cross-functional development team throughout a product development effort to ensure that user needs, usability requirements, and use errors are identified and addressed in the design process.
  • Lead analytic human factors activities (e.g., use FMEA, task analysis, heuristic evaluation) for the purposes of “design input,” risk assessment and mitigation, and protocol development
  • Lead the development and execution of formative and summative evaluations at various stages of product development from early prototypes through formal FDA-mandated validation
  • Work closely with development engineers and R&D Management to ensure the HF/UE process is followed through all phases of the system lifecycle.
  • Engage Quality and Regulatory to drive development of processes documentation to meet regulatory requirements
  • Collaborate with external Human Factor Engineering consultancies, internal stakeholders and partner organizations
  • Advance the development of the Human Factors engineering team by acting as a mentor and leader for less experienced Human Factors engineers.

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Welcome to Balionis Group!

 
 
We have an excellent reputation for matching good Candidates with good Clients. Contact us to discuss how we can help you. Paul Balionis
 

EMAIL or Call (724) 942-5586

 

 
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