Jobs

R&D Specialist - UK

Research & Development
Ref: 330 Date Posted: Wednesday 17 Jul 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, ensure and support compliant, efficient and harmonized technology and product development as well as life cycle management. If you would like to join their mission to improve patient outcomes, minimize discomfort, and accelerate the recovery process for patients, then please get in touch.

 

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Duties and Responsibilities:

 

  • Have awareness and deep understanding of all applicable laws, standards, guidance’s and requirements of the specific expert topic(s).
  • 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.
  • 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.
  • 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 Company 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.
  • Design, development and prototyping of products in accordance with company development standards to meet functional, clinical, customer, regulatory and manufacturing requirements
  • Research and maintain state of the art new product development, materials and manufacturing technologies incl. intellectual property and their application to meet or exceed customer, company and project needs

 

 

Other Related Responsibilities

 

  • Develop 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, development schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly
  • Ensure high product and process quality in collaboration with the quality department and all other departments
  • Evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
  • Generate and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR), Good Manufacturing Practice (GMP), International Standards Organisation (ISO) and in accordance with company development standards throughout the product life cycle to ensure the design is fully documented
  • Coordinate inbound and outbound projects and workstreams in collaboration with external partners (e. g. contract developer or contract manufacturer), ranging from the definition of specifications, buying of products in collaboration with Purchasing, technical assessment and testing of products, and coordination of joint developments.
  • Deliver manufacturable designs acceptable to operations by applying design for manufacture principles and implement feedback from manufacturing engineers, external suppliers and other sources
  • Perform all aspects of QMS-process defined support tasks in developing and sustaining medical devices
  • Cooperation with existing suppliers, independently
  • Contribute to process specific technical solutions including interface topics; lead defined aspects of 3rd party co-operations

 

Education qualifications

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

Experience

  • Some 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 Contextual Inquiry, Human Factors in design, and Usability Engineering.
  • 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.
  • Proven experience of providing subject matter guidance and training on Human Factors Engineering processes and techniques
  • Proven in-depth understanding of the user, the unmet user need, and use environment, and able to communicate this to others for implementation into the conception, design and development of medical devices.

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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