Principal Technology Lead - Cheshire - Medical Devices

Posted 4 September by Bosch Global Associates Ltd
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Principal Technology Lead - Cheshire - Medical Devices

Type: Permanent

Salary: Circa 75k

Location: Cheshire

Purpose of Role

The incumbent will manage a portfolio of Device projects which are likely to be connected through common technology. Will manage individual projects as required: defining milestones, work breakdown, resources, equipment, project inputs, outputs and financial requirements.

Will help define, utilize and leverage appropriate technology platforms.

Will 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.

Conduct device due diligence activities. Contribute to innovation at the platform technology level.

Represent the Steriles Device Team on internal company working groups and represent in industry standard forums.

Essential Duties & Responsibilities:

Support Global Sterile R&D device development activities.

Provide input to the Injectable Device Technology landscape for Steriles in GR&D.

Support of Injectable Device Design activities for Pharmaceuticals Professional Device Network

Provide technical support to define and continuously improve Business Development activities for injectable devices

Manage relationships with contract design houses, contract manufacturing companies and specialist test houses

Evaluate higher barrier value creation product opportunities to be added to further the sterile pipeline

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.

Facilitate ergonomic and user handling studies

Perform risk analysis, FMEA etc.

Manage the Design of and build of product prototypes using CAD and rapid prototyping tools

Skills & qualifications:

  • Education Required: Graduate in Engineering, Physics or similar
  • Education Preferred: Post Graduate Education in Human Factors, Product Development, Business, Manufacturing, Medical Device Regulations
  • Experience Required: Significant track record in management of Medical Device and Combination Product Development . Proficiency in use of project management tools and excel.
  • Experience Preferred: Proficiency in the 3D CAD Design Tools and design detailing.
  • Management of Electromechanical Devices/Systems.
  • Specialized or Technical Knowledge Licenses, Certifications needed:
  • In depth knowledge (through practical experience) of GMP, EU and FDA regulatory requirements
  • Consumer product designer from concept to commercialisation
  • Understanding of device development and manufacturing processes
  • Understanding of device and drug/device combination regulatory requirements
  • Sterile product development knowledge (through experience)
  • Understanding of Electromechanical System Development and Life Cycle Management

MANUFACTURING / QP / QUALIFIED PERSON / QA MANAGER / HEAD OF QA / QC MANAGER / MANAGERIAL / TECH TRANSFER / TECHNOLOGY TRANSFR / DRUG DELIVERY / INJECTABLES / STERILES / STERILITY / COMBINATION DEVICES / MEDICAL DEVICES / PHARMA / PHARMACEUTICALS / GMP / ENGINEERING / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / R&D / PRODUCT DEVELOPMENT / DESIGN / ENGINEER / SCIENTIST / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / NORTH WALES / UK / UNITED KINGDOM / RELOCATE / GSK / GLAXO / BESPAK / ASTRA ZENECA / NOVARTIS / QAIGEN / PFIZER / SANOFI / PRODUCT DEVELOPMENT / ENGINEER / ENGINEERING / CLINICAL / REMEDIATION / PACKAGING / SCIENTIST / SCIENTIFIC / BIOMEDICAL / MEDICAL / HEALTHCARE / REGULATORY AFFAIRS / QA / QUALITY ASSURANCE / FORMULATION / AUDITING

Reference: 35419796

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