Senior Human Factors Engineer

About Pharmavise

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com

Our client has an exciting opportunity for a Human Factors Engineer primarily supporting Structural Heart products within the Interventional Cardiology division. This role will utilize a variety of new and proven technologies to deliver life-changing medical devices to patients and clinicians in support of our client's corporate mission.

This role will apply Human Factors Engineering (HFE) principles to our products across the

product development lifecycle for complex products by partnering with other engineering disciplines, marketing, design assurance, project managers, clinical, and regulatory. Key responsibilities include supporting HFE leads with activities such as summative testing and documentation

Responsibilities

• Understand the basics of the clinical domain and technical knowledge of the system/device to be evaluated
• Working collaboratively R&D HFE team to support the execution of Formative & Summative testing and documentation

Summative Testing with Physicians:

• Support data collection in Summative testing
• Perform Summative data analysis & complete writing up a report

Overall HFE Team support

• Support the R&D HFE team, as needed, with the execution of other Summative testing and documentation (for example, data collection, coordinating builds, and/or Tracking issues & resolutions)
• Lead HFE coordination, alignment, and updates for IFU
• Lead HFE coordinating with cross-functional partners to update Tasks and Use Error Analysis

Qualifications

• 2 year experience with medical device quality systems and developing Class II or Class III medical devices
• Exposure and some experience in the following Human Factors activities:
• 4-year Biomedical, Mechanical, Industrial Design, or other Engineering degree

oCollaborating on Tasks & Use Error Analysis

oAuthoring usability study reports

oWorking with a study coordinator and/or performing recruitment tasks

oUsability testing Data collection

oAbility to analyze data and write up reports

• Leading skills such as strong verbal and written communication, aligning to the project’s schedule, and managing the day-to-day progress independently.

Travel

• Periodic travel to Ireland for team meetings/collaboration may be required (estimated 1 trip)
• Travel to Minnesota but will be required for summative execution (3-5 trips to MN)
• Highly prefer the candidate to be located within commute of the Maple Grove, MN Facility. If not, then additional travel to the MN facility will be required.