Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description:
This is your chance to drive impactful innovation by leading usability studies guiding risk analysis and collaborating crossfunctionally across R&D Regulatory and Marketing teams.
Responsibilities:
- Lead formative and summative usability studies for medical devices.
- Develop detailed usability and risk analysis reports (IEC 623661 ISO 14971 etc..
- Manage human factors deliverables throughout the product lifecycle.
- Partner with crossfunctional teams to ensure safe and effective device design.
- Stay ahead of evolving FDA guidance and compliance requirements.
Requirements:
- 8 years in human factors/usability engineering.
- Strong command of HFE standards and regulatory frameworks 21 CFR Part 820.30 ANSI HE75.
- Proven leadership in human factors for medical device development.
- Skilled communicator and collaborator across disciplines.
Employment Type
Full Time
