Principal Engineer, Design Quality - Software

Olympus Corporation of the Americas

Worcester, MA, US
Base: $119,670.00 - $167,538.00 py; bonus: potenti...
On-site
9 years software development experience
6 years medical device setting experience
Knowledge of iec 62304 iso 14971 standards
Olympus Corporation of the Americas is seeking a Principal Engineer in Design Quality for Software in Worcester, MA. The role requires extensive experience in software development within the medical device sector, emphasizing compliance with regulatory standards and best practices in software design

Job Summary

  • This role provides subject matter expertise and technical guidance for applying health and medical device software regulatory standards to the Olympus SDLC.
  • The position requires advising development teams on architecture, safety, security, and best practices while maintaining compliance with global regulatory domains.
  • Olympus offers a holistic employee experience including competitive salaries, comprehensive medical coverage, and generous paid vacation and sick time.

Matching Summary

Match Score: 85

Olympus Corporation of the Americas is seeking a Principal Engineer in Design Quality for Software in Worcester, MA. The role requires extensive experience in software development within the medical device sector, emphasizing compliance with regulatory standards and best practices in software design.

Salary

Base: $119,670.00 - $167,538.00 per year; Bonus: Potential annual bonus subject to eligibility; Benefits: Competitive salaries, 401(k) match, comprehensive medical/dental/vision, paid parental leave

Skills & Requirements

Must-have

  • 9 years software development experience
  • 6 years medical device setting experience
  • Knowledge of IEC 62304 ISO 14971 standards
  • Experience with FDA PMDA EU-MDR regulations
  • Leadership in QMS integration and audits

Nice-to-have

  • Working knowledge of ML/AI in health software
  • German or Japanese language proficiency
  • Experience interacting with Regulatory Authorities
  • Advanced degree (MS or PhD) preferred
  • Global team collaboration across time zones

Key Requirements

  • BS Degree in engineering or computer science required
  • Minimum 9 years software development experience
  • Minimum 6 years medical device industry experience
  • Project management experience required
  • Strong verbal and written English communication skills

Work Rights

Not specified

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