56 days ago on randstad.ch

Device Development Engineer

Randstad (Schweiz) AG

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Device Development Engineer

Device Development Engineerin Basel

veröffentlicht: Dienstag, 30. August 2016
OrtBasel, Basel-StadtSektorLife SciencesJobtypContractReferenznummer7387KontaktPeter Pankaczi, Zürich Professionals ITTelefon058 201 56 60

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 Device Development Engineer Preferably: a Container Closure Engineer with focus on Pre-Fillable Syringe 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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