Senior Quality & Reliability Engineer

Siemens Healthineers

Issaquah, WA, US
Base: $144,477-$206,870 py; bonus/equity: not spec...
Hybrid
Medical device regulations fda iso 13485
Design failure mode and effects analysis dfmea
Corrective and preventive action capa management
The role involves driving product quality and process compliance during new product introduction and post-market support across cross-functional teams

Job Summary

  • The role involves driving product quality and process compliance during new product introduction and post-market support across cross-functional teams.
  • Candidates will lead design failure mode and effects analyses with an emphasis on strengthening early design and feature development phases.
  • The position requires supporting audits, inspections, and continuous improvement of the quality management system in accordance with international standards.

Matching Summary

The role involves driving product quality and process compliance during new product introduction and post-market support across cross-functional teams.

Salary

Base: $144,477-$206,870 per year; Bonus/Equity: Not specified; Benefits: Hybrid work permitted; 25% travel required

Skills & Requirements

Must-have

  • Medical device regulations FDA ISO 13485
  • Design failure mode and effects analysis dFMEA
  • Corrective and preventive action CAPA management
  • Reliability growth testing and MTBF analysis
  • Software reliability plan implementation
  • Root cause analysis of design non-conformance

Nice-to-have

  • Cross-functional team leadership skills
  • Global platform presentation experience
  • Statistical analysis proficiency
  • Supplier quality management collaboration

Key Requirements

  • Bachelor's degree in Biomedical Engineering or related field
  • Five years of experience as Design Assurance or Compliance Engineer
  • Knowledge of FDA 21 CFR 820, ISO 14971, IEC 62304, MDSAP, and MDR

Work Rights

Not specified

Tailored Resume

Cover Letter