ID EXISTS
POS 2879
Status 5
DJM 1

Mechanical Design Technical Expert

Beschreibung: For one of our Austrian Pharma clients we are seeking freelance support as: Mechanical Design Technical Expert (M/F/D)
Tasks:
  • Lead technical development or lifecycle development activities for medical devices used in combination products eg.  auto-injector or injection pens
  • Specify requirements of delivery system and device components
  • Work with third party suppliers to develop the device components and ensure a robust process is followed (specifications, mechanical design, DfM, DfA, tolerance analysis, risk analysis, testing)
  • Work with third party suppliers to establish robust manufacturing process and map critical to quality design requirements to manufacturing controls
  • Oversee design, qualification and validation activities of manufacturing processes (injection molding and assembly) at suppliers by reviewing tool and assembly equipment designs, as well as qualification reports.
  • Ensure components are delivered and controlled to the required quality for clinical trials and commercial production
  • Report in to the Device Project Leader and Delivery System Leader on all technical aspects related to the device development project
  • Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing
  • Generate Design Controls documentation while contributing to a high-quality Design History File delivery injection systems
  • Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report
  • Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
  • Ensure device design development in compliance with the regulations and delivered to a high quality
  • Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence
Qualification:
  • Start: 01.07. / 6 Months / Full-time
  • Practical experience of at least 5 years in product development and design within medical devices or drug delivery industry
  • experience of mechanical design and industrialization of manufacturing process
  • Good technical knowledge of medical devices
  • Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
  • General understanding of Human Factors Engineering and Risk management
  • Must have: business fluent in English
Bemerkungen: WANTED: Mechanical Design Technical Expert (M/F/D). Please contact +49 89 18 90 998 30 or maria.haushofer@k-recruiting.com

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Skills: 21 CFR Part 820 (Quality system regulations for medical devices), Combination product, English, MDR / MDD (Medical Device Directive / 93/42 EEC), Medical Devices, Pharma, Product Development
Interesse geweckt?
Auf geht's!
Beginn: 01.07.2019
Laufzeit: 6 months +
Einsatzort: Austria
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