Senior Engineer, Design Assurance
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About the role
Masimo develops medical monitoring technologies and patient-care solutions. The Design Assurance Engineer will maintain design records, assess product risks and changes, and support validation and post-market quality activities.
What you'll do
- Manage and audit Design History Files for compliance
- Review design requirements, change orders, and validation plans
- Maintain risk management files alongside design changes
- Review test method validation protocols and reports
- Monitor post-market feedback and prepare performance reports
Skills
Must have
- Quality engineering
- Design controls
- Risk management
- Gd&t
- Design history file documentation
- Pfmea
- Dfmea
- Ufmea
- Verification and validation
- Test method validation
Nice to have
- Six sigma green belt
- Certified quality engineer
Tools
- Microsoft office
Who it's for
- Experience
- 3+ years
- Domain
- medical devices
About Beckman Coulter (Danaher)
Beckman Coulter (Danaher) has 52 open roles in Bangalore, at Beckman Coulter Indian Development Centre. See every Beckman Coulter (Danaher) role.
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