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SeniorFull-timeAWSGit
Salary Range
$132,600 - $179,400 /year
This salary is estimated based on similar roles. The actual salary may vary.
Key Responsibilities
- →Lead design control strategy in compliance with FDA 21 CFR 820.30, ISO 13485, and global regulations
- →Facilitate design reviews and ensure phase-appropriate deliverables are complete and audit-ready
- →Lead development and maintenance of risk management files in accordance with ISO 14971
- →Define and lead V&V strategy, including protocol development and final reporting
- →Ensure integrity and completeness of the Design History File (DHF)
- →Partner with Regulatory Affairs to support submissions
- →Mentor junior engineers on design control and risk management best practices
- →Lead and own CAPAs related to design control activities
Requirements
- ✓Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or related field
- ✓5–8+ years of experience in medical device development within Quality or R&D
- ✓Demonstrated experience owning design controls and supporting at least one FDA 510(k) submission
- ✓Deep understanding of FDA design controls, ISO 13485, and ISO 14971
- ✓Strong proficiency in statistical methods, risk management tools, and root cause analysis
- ✓Experience authoring complex protocols, validation reports, and SOPs
- ✓Experience working within an electronic QMS
- ✓Excellent written and verbal communication skills
Benefits
- ★Competitive salary & equity compensation
- ★Unlimited PTO, company holidays, and quarterly mental health days
- ★Comprehensive health benefits including medical, dental & vision, and parental leave
- ★Employee Stock Purchase Program
- ★401k benefits with employer matching
- ★Offsite team retreats
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