Product Development Engineer

vor 3 Wochen


Bern, Bern, Schweiz Consultys Vollzeit
Job Description

As a Combination Product Device Development Engineer at Consultys, you will be responsible for developing and executing Human Factors Engineering plans in accordance with current standards and guidelines. This includes writing and reviewing HF study protocols, supporting report reviews, and resolving issues arising from internal quality assessments and regulatory inspections.

You will also be responsible for creating, reviewing, and approving design control documents, such as design verification and validation protocols, risk management plans, and design review meeting minutes. Additionally, you will ensure data integrity and scientific consistency in all verification testing and promote data analysis using advanced statistical techniques.

Key responsibilities include:

  • Developing and executing Human Factors Engineering plans
  • Writing and reviewing HF study protocols
  • Supporting report reviews and resolving issues arising from internal quality assessments and regulatory inspections
  • Creating, reviewing, and approving design control documents
  • Ensuring data integrity and scientific consistency in all verification testing
  • Promoting data analysis using advanced statistical techniques

Requirements:

  • At least 5 years' experience in Pharma Device Development
  • University degree in a relevant field of science, such as engineering, biotechnology, or biochemistry
  • Strong scientific background in all aspects of primary packaging and drug delivery
  • Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies
  • Experience with test method development, Combination Product Verification Testing, and specification generation

We are looking for a highly experienced and skilled engineer who can work closely and efficiently with employees and colleagues of all levels. If you have a strong scientific background and experience in Pharma Device Development, we encourage you to apply for this exciting opportunity.



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