Senior Design Quality Engineer
Caris Life Sciences
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $106,000 - $112,000 per year
Job Level
About the role
- Responsible for creating the Design and Development Plan (DDP) for new development projects
- Create and maintain risk management file with support from cross-functional teams include risk management plan/report, hazard analysis, dFMEA, uFMEA.
- Provide mentorship, guidance and training to product development teams new to design controls and risk management processes.
- Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.
- Manage deviation and issues for verification and validation activities.
- Support design reviews and design transfer activities including process validations, pFMEA and DMR.
- Support design changes and post market activities, ensuring product safety.
- Perform risk assessments for regulatory submissions.
- Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.
Requirements
- Bachelor’s degree in engineering, scientific or related field
- Minimum 4+ years of hands-on experience, or relevant comparable background.
- The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports.
- Working knowledge of design controls, risk management and product development processes.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
Benefits
- Health insurance
- 401(k)
- Paid time off
- Flexibility in work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk managementdesign controlsverification and validationhazard analysisdFMEAuFMEAprocess validationpFMEAtechnical documentationgap analysis
Soft Skills
mentorshipguidancetrainingcommunication
Certifications
Bachelor’s degree in engineeringBachelor’s degree in scientific fieldBachelor’s degree in related field