SUMMARY- 3 Positions Open (Pittsburgh, PA Memphis, TN & Andover, MA)
Leads the Human Factors Engineering effort across a program of projects. This includes gaining understanding of users and their requirements through to defining the strategy to evaluate and prove the design to ensure that products developed are safe and effective to meet regulatory requirements. As a functional expert provides guidance in order to incorporate usability/human factors into the design process for all relevant products and supports changes to the user interface where necessary in order to successfully achieve challenging and time critical objectives.
Human Factors Research
Leads research across multiple program to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints.
R&D Project Delivery
Supports the delivery of projects by developing and leading strategies, informing on design through research with users, expert review and literature, design iteration following testing, managing external experts and compiling reports for submission to regulatory authorities.
Current product support
Provides ongoing assessment where changes to an existing product user interface are proposed to identify any additional work required.
Usability Process development
Develop and maintain the usability process in order to streamline product development
Develops and maintains an understanding of the latest information regarding usability/human factors testing for medical devices and makes recommendations internally about any changes. Maintains a network of external contacts who can be referred to for advice when appropriate.
To ensure all activities are performed in accordance with relevant national and international standards. Specifically IEC62366 - 1
Health & Safety: To promote health and safety policies and procedures to encourage a safe working environment.
Travel Up to 25%
Minimum BSc in relevant area (Human factors
Human Factors/Ergonomics qualification an advantage
6-8 years’ experience in the application of Human factors Engineering to product/system design.
Experience of Project Management Experience of third party management (budget >£100k)
Significant working knowledge of Usability/Human Factors Engineering in a medical device environment.
Experience of moderating user studies.
Knowledge and experience of IEC62366
Experience of working to FDA guidelines
Strong organizational , prioritization and communication skills.
Knows the business
Focuses on the customer
Builds strong relationships
Embraces Innovation and Change
Delivers on commitments
Microsoft Office Suite: Word, PowerPoint, Excel, Outlook, Project and Visio
Not a budget holder but responsible for selecting partners and defining / monitoring Scope of Work which may exceed $100k
Will supervise and coach more junior team members
This role will predominantly involve communication with other functions at a similar level and functional managers of other departments.
Extensive communication with third party experts.
Works across R&D with responsibility for Human Factors on project program.
Limits of Authority
Will take advice regarding overall strategic direction on projects from HF Director. Requires little to no supervision in day to day activity.
Internal Number: R29201
About Smith & Nephew
Smith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.
We have leadership positions in:
• Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders
• Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
• Sports Medicine - minimally invasive surgery of the joint
• Trauma & Extremities - products that help repair broken bones
We have around 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NY
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