device development engineer in Basel

basel, bâle-ville
life sciences
type d'emploi
numéro de référence
peter pankaczi, zürich professionals it
058 201 56 60
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description du poste

  Device Development Engineer
  Preferably: a Container Closure Engineer with focus on Pre-Fillable
  Main Purpose of the Mission
  The Device Development group within the company is responsible
  for development and support of medical devices and drug delivery devices
  for combination product portfolio.  Our activities span a range of
  engineering disciplines from the requirements definition phase through to
  commercialization and marketed product support. For Late Stage
  Development Project we are looking for support in technical documentation.
  The specific responsibilities of this challenging position within our Device
  Development Team include:
  · Apply mechanical engineering skills to create innovative, reliable and
    effective medical devices
  · Apply scientific approach to run Design of Experiments (DOE)s and
    feasibility studies to help enable material selection and device
    design confirmation
  · Perform Risk Analysis as part of device development
  · Provide high quality input and documentation for interaction with
    regulatory authorities. Drive device development for biologics to
    new states and standards as needed by our portfolio
  · Collaborate effectively with partners in Technical Research and
    Development, Quality, Commercial Manufacturing in developing
    aligned strategies and concepts for the development of
    Combination Products for Biologics and ensuring seamless
    handover of projects and aligned development of technologies
    and knowledge.
  · Apply your knowledge of the regulatory landscape to ensure
    standard compliant designs, working to Quality Management
    Systems such as ISO 13485, and 21CFR820, risk management to
    ISO14971, design control, compilation of Design History File,
    verification and validation and clinical trial/manufacture support
  · Develop mathematical and statistical models to understand impact of
    primary packaging attributes on drug administration. Utilize
    engineering and analysis tools to ensure robust designs and
    understand device limitations (e.g. root cause analysis, tolerance
    analysis, finite elements analysis, probabilistic design)
  · Maintain knowledge of relevant legislation, regulation, and industry
    trends in the field of Medical Devices and Combination Products.
Maintain own specialist expertise through exposure, education, training, and application. Comply with internal and external requirements in all aspects of operations. Act in compliance with Pharmaceutical Quality System, local Standard Operating Procedures, Corporate Values and Behaviours.       Qualification:                  The ideal candidate will have the following skills and qualifications:  
  • >7 (ideally >10) years proven track record in strong engineering discipline (mechanical engineering preferred, but other disciplines also will be considered)
  • Experience in primary packaging development
  • Enthusiastic team player with good communication and collaboration skills
  • Good analytical, practical, and creative skills
  • Demonstrable knowledge of parenteral drug container and delivery (including devices such as pre-filled syringes, closure systems, auto-injectors, needle safety devices, or other novel injection technologies)
  • Strong market awareness/network and a capability to identify and develop new technology opportunities
  • Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices
  • Sound analytical skills
  • Sound leadership skills
  • Some knowledge of material sciences preferred
  Languages: Excellent command of English language and German
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