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R&D Specialist - UK

Research & Development
Ref: 330 Date Posted: Tuesday 01 Oct 2019
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Our Client designs world-leading, clinically-advanced, precision technologies that enable healthcare professionals, to ‘peer’ inside the body, using endoscopic procedures. By focusing on early detection and minimally invasive treatment of a broad range of diseases, they focus on improving patient care quality every day.

Currently, they are looking for an R&D Specialist to manage activities to ensure harmonized technology and product development as well as life cycle management are focused on the practical and pragmatic implementation of user-centred techniques to generate commercially successful safe and usable medical products in line with regulatory compliance.

 

Key Result Areas:

 

  • Provide technical subject matter guidance & training to others on Human Factors Engineering processes and techniques.
  • Generate or manage the technical Human Factors Engineering activities on project(s).
  • Support the definition of user needs/requirements, gathering activities including ethnographic research, use case analysis, and/or task analysis.
  • Lead or manage the analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations.
  • Conduct and assist with a range of formative usability studies during development, Design Validation and summative usability studies for human factors validation.
  • Maintain a strong and current understanding of human factors engineering discipline and regulations.
  • Provide technical subject matter guidance & training to others on Human Factors Engineering processes and techniques.
  • Generate or manage the technical Human Factors Engineering activities on project(s).
  • Support the definition of user needs/requirements, gathering activities including ethnographic research, use case analysis, and/or task analysis.
  • Lead or manage the analytical use risk analysis to predict and/or assess use error risk potential and identify design mitigations.
  • Conduct and assist with a range of formative usability studies during development, Design Validation and summative usability studies for human factors validation.
  • Maintain a strong and current understanding of human factors engineering discipline and regulations.

 

 

Duties and Responsibilities:

 

  • Have awareness and deep understanding of all applicable laws, standards, guidance’s and requirements of the specific expert topic(s).
  • Transfer information from all relevant laws, standards, guidance’s and requirements into lean internal processes (including process ownership) to foster efficient and compliant product development and life cycle management.
  • Generate or manage all applicable process documentation & design interface development in compliance with external (e.g. Standards) and internal (e.g. processes) rules and requirements concerning technology and product development as well as product lifecycle management.
  • Participate in internal and external expert working groups (e.g. standard development committee) to influence preparation and/or understanding of relevant upcoming regulations.
  • Interact with parallel functions in other group companies to facilitate global harmonization and contribute to Olympus success.
  • Roll out projects and activities in specific expert topic(s).
  • Act as internal and external consultant in diverse interfaces (e.g. other departments, S-BC, Customers).
  • Act as internal consultant for management in terms of strategic trends of respective expert fields.
  • Cooperate with suppliers and develop strategies for future supplier portfolio optimization together with global sourcing.

 

Other Related Responsibilities:

 

  • Support the generation of timelines cost and resource estimates for development tasks to appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule.
  • Progress vendor activities in agreement with global sourcing relative to communication of specifications, developments schedules and tracking in order to provide services for Human Factors Engineering activities.
  • Ensure high product and process quality in collaboration with the quality department and all other departments
  • Support Product Management with the Design Validation of the product

 

Education qualifications

  • Bachelors or master degree in Engineering or equivalent professional or equivalent skill and knowledge gained through significant practical experience

 

Experience

  • Many years of experience in a regulated and highly industrial or scientific engineering design environment
  • Project experience
  • Experience and understanding of intellectual property

 

Specific skills

  • Relevant technical knowledge in expert topic(s)
  • Experience in medical device development - preferred
  • Deep technical knowledge in at least one specific area 
  • Strong problem solving skills independently
  • Promote collaboration in a team
  • Ability for proactive identification of opportunities for business success or efficiency improvement
  • Understanding interfaces between functions, understanding of the needs of others. Ability to see the bigger picture

 

Human Factors Engineering Specialist Specific Requirements

 

  • Educational Qualification in Human Factors or Engineering related discipline
  • Applied knowledge and detailed understanding of use research, user interface design & Human Factors in design & usability evaluation.
  • Understanding of current medical device Human Factors standards and FDA Guidance (ie. ISO/IEC-62366-1, ANSI/HE-75, etc.
  • Proven experience of the tools and techniques required to apply Human Factors principles and Usability Engineering to products in development.
  • Knowledge of FDA and MDD requirements for the application of Human Factors to medical device design is highly desirable.
  • Empathy and excellent communication with study participants – previous experience moderating usability studies is highly desirable.

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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