Senior Principal Engineer, Human Factors — CSL Behring

CHF 94'500 - 143'000
CSL Behring · Bern (BE)
Categoria: Ingegneria Contratto: full-time Salario: CHF 94'500 - 143'000
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Location
Bern
Contract
full-time
Posted
43 days ago
SalaryCHF 94'500 - 143'000

Role overview

This role is a position in the Drug Delivery Systems & Packaging (DDSP) department within CSL Technical Operations.

The ideal candidate has a solid track record in the development of drug delivery devices, from concept development through commercialization and product maintenance.

This role requires experience in leading user interface development and a passion for making the right product that meets the needs of the patients.

Main responsibilities

  • Act as Lead Human Factors Engineer
  • Plan and execute Human Factors Engineering activities in drug delivery device projects, including development of secondary packaging and Instructions for Use
  • Set and drive best practices within DDS&P for Human Factors Engineering
  • Support standardization of approaches for Task Analysis, Use Risk Assessment, and other key deliverables
  • Lead HF oversight of secondary packaging development
  • Partner with project leads and the cross-functional development team on planning and execution of projects
  • Lead development of selection criteria and evaluation of the user interface for new products
  • Collect, maintain, and utilize data on user capabilities and known use problems with combination products
  • Contribute to the development of Company Core Data Sheets (CCDS)
  • Plan and execute Formative and Summative evaluations, including selection and oversight of CROs

Key requirements

  • Excellent communication skills and a track record working in a matrix environment
  • Ability to influence and promote a culture of continuous improvement Subject Matter Expertise on:
  • IEC 62366 family of standards and related regulatory guidance User Capabilities – anthropometric basis Use Risk Assessments Proven track record of:
  • Evaluation of user interfaces for drug delivery devices
  • Development of instructional materials for product labelling and artwork
  • Relevant academic qualification in an appropriate field, e.g., Ergonomics, Psychology or a suitable Science or Engineering degree
  • At least 8 years of related experience in the pharmaceutical or medical device industry
  • Ability to travel internationally up to 20% About CSL Behring
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
  • Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
  • We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
  • CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.

Additional details

  • Ability to influence and promote a culture of continuous improvement Subject Matter Expertise on:
  • IEC 62366 family of standards and related regulatory guidance User Capabilities – anthropometric basis Use Risk Assessments Proven track record of:
  • Ability to travel internationally up to 20%
  • To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . For more information on CSL benefits visit

Notes and original content

  • Responsibilities
  • Qualifications
  • Ability to influence and promote a culture of continuous improvement
  • Subject Matter Expertise on:
  • IEC 62366 family of standards and related regulatory guidance
  • User Capabilities – anthropometric basis
  • Use Risk Assessments
  • Proven track record of:
  • About CSL Behring
  • To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Apply now
Logo CSL Behring
Company
CSL Behring · Bern
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