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Sr. Manager, Human Factors Lead

Employer
NextSense, Inc
Location
San Francisco, California
Closing date
Jan 29, 2022

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Position Type
Dean / Department Head
Hours
Full Time
Organization Type
Business
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About NextSense:

NextSense's vision is to be the foundation of brain health and establish a new paradigm

in neurocare . Powered by a disruptive brain-sensing earbud technology and digital ecosystem, our mission is to establish new ways of diagnosing and optimizing therapy for diverse neurological conditions. We hope to unlock brain health for everyone with real world data insights and practical, scientific wisdom for daily living.

We are seeking a highly experienced and motivated Sr. Manager, Human Factors leader to join our Product leadership team.You will be a key leader in collaborating effectively with cross-functional teams including clinical, medical affairs,, engineering, quality, manufacturing and regulatory to apply human-centered design methods through implementation of usability process, determination of desired user profiles and environments, development of user documentation, and creation of usability files.

Roles and Responsibilities:

  • Manages all usability and user research studies from early to late stage of device development providing input to delivery system design and development.
  • Provides expert Human Factors input to engineering groups based on usability activity results and design principles.
  • Conducts use related hazard analysis and facilitation of Failure Modes and Effects Analysis
  • Prepares technical documents for usability files within the DHF and as input to regulatory submission.
  • Lead a team of usability/ human factors engineers
  • Ensures that user capabilities and limitations and their associated use-related risks are appropriately addressed in planning, requirements development, and risk management.
  • Ensures that performance characteristics and their associated benefits and risks assist in deciding among design alternatives
  • Design product concepts in a human-centered way that balances vision, speed, business potential, clinical needs, technical requirements and regulation.
  • Design the best medical device that's clinical grade yet with the simplicity and elegance of a modern consumer device.
  • Create a product experience that seamlessly dovetails between hardware and software.
  • Create quick hardware prototypes using the latest prototyping tools to gather iterative real world user centered feedback.
  • Present deliverables that may include research summaries, sketches, user scenarios, physical prototypes, product renderings, animations, and appearance models.
  • Contribute strategic thinking to product features and roadmap


Required Qualifications

• Min BA/BS degree in Industrial Design, Biomedical Engineering, Mechanical Engineering, Human-Computer Interaction, Psychology, Human Factors, Anthropology or other related fields or equivalent practical experience

• 7+ years of experience designing connected device products and systems. You can seamlessly move between end to end hardware/software design process from user interviews, wireframing, prototyping, and industrial design. You have a passion for materials and material exploration. You have experience launching hardware/software products that are awe inspiring and clinically functional.

• Regulation Experience. Experience with regulated medical product development including incorporating FDA human factors regulations. Understanding of and experience with relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidances.

• User First. You advocate first and foremost for the user. And can think through the complex system of users within healthcare weighing motivations, needs, user journeys of each user where relevant within the product suite. Have knowledge of and experience with a wide range of accessibility principles to ensure a simple and elegant user experience.

• Evidence Based Design Decisions. Ability to garner and understand qualitative and quantitative feedback.

• Excellent communication skills. You can share design processes and decisions across all stakeholders confidently and with relevant evidence backing these decisions.

• Collaborative partner. You can work closely with product, engineering, designers and other stakeholders to move a product along. Ability to influence larger team with human centered design principles and effective design processes.

• Growth Mindset. You are curious and open to receiving and providing feedback, and can adapt to a fast moving environment.

• Efficient Workflows. Excellence in Industrial design tools (CAD, Adobe Creative suite, Miro, Figma etc), rendering and presentation software

Additional Skills And Preferences
  • In-depth technical knowledge of HF methods and deliverables throughout the entire product development lifecycle that ensures compliance to relevant standards and FDA guidance
  • Demonstrated capability in the development of usability study protocols and reports including usability root cause analysis and risk benefit analysis
  • Familiarity with managing consulting relationships to execute usability activities
  • Experience with software and/or electromechanical systems
  • Demonstrated ability to work effectively across boundaries and influence to drive organizational culture change
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