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Medical Device Engineer (f/m) in Basel

Medical Device Engineer (f/m) in Basel

Job Title: Medical Device Engineer (f/m) in Basel
Contract Type: Permanent
Location: Basel, Switzerland
Industry:
Salary: Negotiable
Start Date: asap
Reference: SPPO2206_1498126155
Contact Name: Petra Ognjenovic
Contact Email: p.ognjenovic@sciproglobal.de
Job Published: June 22, 2017 11:09

Job Description

Device Engineer in Device Development (f/m) in Basel

The Device Engineering Team combine design, engineering, testing, and manufacturing to develop drug delivery devices. The role will require considerable cross-functional interaction, notably including Quality Assurance, Regulatory Affairs, Clinical Affairs and Commercial functions. This role will report directly to the Head of Device Engineering

Your responsibilities

  • Ensure Quality Management Systems (ISO 13485, 21CFR820)
  • Risk Management (ISO 14971)
  • Design control (21 CFR 820.30)
  • Technical specifications
  • Design control documentation (e.g. Design Development Plans, User Requirements Specifications, DHF creation/maintenance DHF)
  • Authoring, compilation and maintenance of Design History File
  • Conformity Assessments
  • Design Verification Plans
  • Establish robust technical product requirements
  • Develop engineering design solutions to assure devices
  • Forecasts for device development projects
  • Execute projects within the agreed time, quality and cost constraints

Qualification:

  • University level education (engineering degree or related discipline)
  • 3+ years of experience as mechanical engineering
  • Experience in drug delivery device development
  • Very good know how regulation, industry standards and guidance
  • Experience with combination products and/or medical devices is a very strong plus
  • Very good in the interaction with Health Authorities
  • Fluent level of Business English, German is a strong plus (at least B1 Level acquired)

SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress?

Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de

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