SENIOR HUMAN FACTORS SCIENTIST/ENGINEER - CAMBRIDGESHIRE
Salary: 50-70k dep. on experience.
Benefits and Bonus: Yes.
Travel: Yes, globally.
Purpose of the role:
The main purpose of this position is to manage the Human Factors, Industrial Design, and Market Reference Inputs into Injectable Devices and other Devices as required within GLOBAL R&D. To ensure device developers and suppliers adhere to quality by design, cGXP's, appropriate pharma and device regulations and control the acceptance and maintenance of Device documentation.
Develop and introduce the appropriate processes required to ensure compliance to FDA guidelines and ISO standards and to ensure the provision of Human Factors reports necessary to support regulatory submission.
- To support the Global Sterile R&D device development activities
- To provide input to the Injectable Device Technology landscape for Steriles R&D.
- To support the Injectable Device Design activities for Pharmaceuticals Professional Device Network
- To provide technical support to define and continuously improve Human Factors and Market Preference activities for injectable devices
- To manage relationships with contract design houses, human factors and ergonomics consultants and specialist test houses
- To contribute to and conduct product design activities and human factors studies
- To contribute to and lead needs identification work
- Oversee the design and development of drug delivery devices
- Identify improvements and adaptations to existing devices
- Facilitate, support and/or project manage the development, verification and validation of device prototype
- Oversee the generation of 3D design and 2D detailed design
- Identify opportunity to generate intellectual property
- Compile documentation in accordance with relevant regulatory requirements
- Project management: Lead projects including regularly reviews of all 'scheduled product development’ activities
- Prepare product presentations to include product business model, industrial design, ergonomic design, user needs, unmet user needs, user interface, user steps, user risks, functional description, technology and product feasibility assessment and cost-of-goods estimates.
Graduate in Industrial Design, Ergonomics or similar
Post Graduate Education in Human Factors, Product Development, Business, Manufacturing, Medical Device Regulations
Experience of Product Development.
Market preference and use needs analysis, validation activities
Proficiency in the creation of regulatory submission reports for medical devices and combination products.
Management experience of Medical Device and Combination Product Development.
Experience of market preference and use needs analysis, Experience of formative and summative validation activities
Indepth knowledge (through practical experience) of GMP, EU and FDA regulatory requirements
Consumer product designer from concept to commercialisation
Human Factors standards, guidance and best practice
Understanding of device and drug/device combination regulatory requirements
60601 / 60602 / MECHANICAL DESIGN / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO MECHANICAL / QA / QUALITY ASSURANCE / QA ENGINEER / QUALITY ENGINEER / GMP / STERILES / ISO13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / PHARMA / PHARMACEUTICAL / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3 / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / R&D ENGINEER / RESEARCH ENGINEER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / ELECTRO MEDICAL / ELECTRO-MECHANICAL / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / FRANCE /GERMAN / IVD / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / DRUG DELIVERY / CAREFUSION / SIEMENS / TUV / SGS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / RELOCATE / SWEDEN / AUSTRIA / BELGIUM / NETHERLANDS / FRANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / ALARIS / OWEN MUMFORD / BIOMET /SIEMENS/BIOTRONIK/GAMBRO/FRESENIUS/SANOFI/CR BARD / BAXTER / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / DRUG DELIVERY / CAREFUSION / SIEMENS / TUV / SGS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / INJECTION / TALLEY GROUP / INFUSION / DESIGN / UK / RELOCATE / CHESHIRE / LIVERPOOL / MANCHESTER / RUNCORN / LIVERPOOL / MACCLESFIELD / CHESTER / STAFFORDSHIRE / MIDLANDS / NORTH / LANCASHIRE / MECHANICAL ENGINEER / MECHANICAL ENGINEERING / CATALENT / INJECTION / INJECTABLES / MOULDING / NORTHWICH / EUROPE / COMMERCIAL / BUSINESS MANAGER / DIRECTOR / MANAGER / TECHNOLOGY / DRUG DELIVERY / MEDICINAL / STERILE / GSK / GLAXO / BOOTS / PFIZER / WYETH / HUMAN FACTORS / INDUSTRIAL / PATENT / RESPIRATORY / COMBINATION PRODUCTS / HUMAN FACTORS / ERGONOMICS / INDUSTRIALISATION / USABILITY / PACKAGING / TECHNOLOGY / TECHNOLOGIST / PRODUCT DEVELOPMENT / FORMULATION / CLINICAL RESEARCH / CLINICAL TRIALS / SCIENTIFIC / SCIENTIST / ASTRA ZENECA / ROSEMONT / ERGONOMICS
- Human Factors
- Usability Engineering
- MEDICAL DEVICES